Careers with Cirtec – Medical Device Design, Development and Manufacturing
We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference.
If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.
To view all current positions and apply online, visit the Cirtec Career Center:
Opportunities in Brooklyn Park, MN
Neurostimulation Leads Design Engineer
Defines, develops and designs Neurostimulation leads, owns efforts in developing solutions to product design, and design for manufacturability. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of management and production personnel. Prioritize tasks based on direction given by management to ensure all project deliverables are completed successfully.
- Owns the design and development of Neurostimulation leads through:
- Performing timely research
- Transforming customer Neurostimulation leads expectations into results
- Developing full design requirements, product design, specification creation with mechanical and electrical components and assemblies
- Creating Test methods, Design verification and validation activities
- Process development, qualification and validation
- Design and build prototype fixtures and tooling, defines equipment needs
- Sourcing materials for prototype builds
- Transferring to manufacturing and may support existing product lines
- Operator training
- Clinical builds
- Plans, schedules, conducts, and coordinates detailed phases of engineering work in projects of technical/design scope. Makes suggestions for and may implement design improvements to meet user requirements
- Performs problem solving, task planning, design review activities, requirements generation, customer communication, and any other skills as designated
- Provides regular status updates to management and or customer
- Performs design reviews and pre-validation assessments to ensure a safe and environmentally sound start-up of new design/technical recommendations
- Works with sales to review and evaluate new opportunities and provide technical assessment of risk
- Writes/updates work instructions, part specifications, validation protocols, and various technical documents
- Other duties as assigned
- FDA cGMP principles and practices
- Owning and/or participating in DFMEA, PFMEA, and Risk analysis activities
- Development of user requirements and product requirements documentation
- 5+ years’ experience in the Neurostimulation Leads medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices
- Materials Biocompatibility
- Creating and developing of specifications and relevant test methods
- Design verification and validation
- Design for Manufacturing (DFM)
- Possess a strong desire to always learn or design new technologies associated with Neurostimulation leads.
- Pro-E / CREO and or SolidWorks
- Understanding of mechanical and electrical assemblies
- Must be able to read, write and speak fluent English
- Excellent reading, writing, communication, and organizational skills
- Experience/Expertise in experimental techniques including statistical analysis, DOE and validation
- Experience in the medical device industry and Six Sigma or process excellence tools/methodologies is preferred
- Injection molded, extruded, and machined parts
- Must maintain high ethical standards
- Must demonstrate good organizational skills
- A BS degree in relevant engineering discipline with a minimum 5 years of related engineering experience, or its equivalent design related experience
- Possess a basic understanding of engineering theoretical fundamentals including a basic knowledge of materials science, electrical and mechanical engineering principles
The Quality Inspector ensures that all Cirtec products meet requirements for both visual and mechanical inspections as required based on print and inspection plans. Strict workmanship standards have been established and are taught to each employee.
- Must demonstrate ability to perform visual inspections with microscopes at specified magnification and with a Visual Measuring System
- Must be able to use Visual Measuring System and develop required statistical data
- Ability to decipher blueprints and inspection plans to fully understand customer quality requirements
- Attain knowledge of all Cirtec’s procedures, work instruction and forms related to your job process
- Maintain a clean and orderly work area on a consistent basis
- Communicate the quality status of all styles to the Inspection Lead
- Read and follow Cirtec’s handbook and maintain an attendance and tardiness record within the set limits of company policy
- Other tasks as assigned
- Must have a minimum of two years final inspection experience
- Self-Starter, ability to handle multiple priorities, and detail oriented
- A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection tools, and mechanical measuring tools
- Excellent written and verbal communication
- BS/BA/BE, AA, or applicable experience
Design Quality Engineer
This position will be responsible for product remediation gap analysis and maintenance of the remediation process throughout the organization. Remediation engineering activities for selected products includes review and gap assessment of design requirements, risk management, standards, component and system level specifications, test method validation, component/contract manufacturer qualification and process validation.
- Execute a risk based approach/procedure/plan for remediation of design requirements/specifications, technical standards, test methods, supplier controls and manufacturing controls grounded in FDA requirements and technical standards.
- Work closely with both internal groups and external groups to assess and potentially redefine or clarify system level requirements, Use-Conditions and risks for project.
- Responsible for the assessment of technical standards, labeling and technical file requirements to characterize gaps.
- Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
- Perform requirements flow down analysis on critical to quality product performance specifications down to components and process.
- Apply Design for Reliability and Manufacturability tools and techniques to remediation projects as appropriate
- Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations.
- Prepare or direct the preparation of oral and written reports of gap analysis as required by the project or department management.
- Prepare tradeoff studies and implementation alternatives to mitigate gaps.
- Perform required training and certifications to demonstrate compliance with applicable divisional and corporate policies in accordance with individual training matrix.
- Collaborate with management to ensure effective and robust risk management for products and processes.
- Utilize quality systems expertise by assisting in continuous improvement activities throughout the organization as driven by product lifecycle management considerations.
- Support CAPA Board meetings and assist following-up on open action items until closure.
- Support initiatives to ensure effective reporting of quality improvement program metrics.
- Perform other duties as assigned.
- Bachelor’s Degree in an engineering discipline
- 7+ years of design, quality, or reliability engineering experience in a highly regulated environment (5+ years with MS in engineering discipline)
- 3+ years of medical device experience
- Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations
- Experience in the medical device industry
- Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation.
- Knowledgeable of product development processes and methods.
- MS Degree in Engineering, Physical /Biological Sciences with RAC or CQA Certification
- Knowledge in the application of risk management
- ASQ Certification
Effectively operate a laser cutting or welding machine and monitor quality work at an acceptable rate. Keep the area that they are working in and follow the cleanroom cleaning procedure. Able to read and comprehend blue prints for client requests. Communicate with departing shift to learn the status of jobs in progress.
- Previous laser machine experience (1-2 years)
- Experience with high tolerance cutting, welding and drilling of metals
- Blue print reading
- Availability to work overtime (shift and weekends)
- Previous experience working in a cleanroom environment
CNC Milling Machinist
To set up and maintain all set-ups on CNC machinery. To be self-motivated and ensure the product is done on time and of the highest quality possible. To have excellent trouble shooting ability on both the machine and tooling and to assist the supervisor and/or lead person as well as the programmers with the operation of the department.
- Accurately complete all department paperwork including job travelers, inspection documentation, and work packet information and tooling request forms
- Have a general understanding of Cirtec Medical workmanship standards
- Be able to maintain an acceptable efficiency operating machinery
- Have the ability to change most types of tooling used in various machines
- Active participation in team meetings and improving quality programs
- Be familiar with functions of the machine including tool and work offsets and be able to adjust them to ensure quality components are being manufactured
- Demonstrate concern for equipment by proper use of all equipment and maintaining a clean work environment
- Demonstrate an ability to use inspection equipment as required, including vision systems
- Have the ability to solve problems to maintain quality and efficiency while working within the team
- Have a good attendance record
- Have the ability to pass internal blue print reading and workmanship tests
- Understand company policies and procedures
- Maintain a high level of quality
- Excellent working knowledge of blueprints and geometric tolerance
- Interact effectively with engineering and quality individuals to solve problems that may arise in a professional and timely manner
- Have extensive knowledge of all phases of machining and equipment
- Demonstrate good decision making and problem solving
- Continually train co-workers to encourage individual growth within the team and within the company
- Have the ability to set up and run all jobs within the department
- Promote good morale and productivity
- Have the ability to increase production and streamline set-ups for optimum efficiencies and quality
- Have the ability to trouble shoot quality problems by effectively utilizing process control and corrective actions
- Maintain a very high level of cleanliness and organization and promote this within the team
- Ability to interpret tolerances, GD&T, dimensions, finish requirements, part views, etc. on engineering blue prints
- Minimum of 3 years of experience with set-ups, operating and troubleshooting CNC vertical mills
- Ability to operate vision systems and inspection equipment
Business Systems Manager - Can be based in MN or CT
This individual is responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications. This individual will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines. In addition, he or she will analyze sales opportunities and support the approval process. Finally, this individual will be responsible for developing dashboards and other strategic sales reporting tools.
Outcome Required & Strategic Priorities:
- Develop and implement quote process for new development and manufacturing opportunities
- Develop quote metrics
- Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met
Main Responsibilities / Critical Tasks:
- Coordinate all quoting activities for Cirtec’s Brooklyn Park and Enfield operations.
- Develop quote metrics and report to management periodically
- Meet with perspective customers to understand needs and develop quote based on inputs
- Assist with sales pipeline management
Skills & Knowledge:
- Technical Bachelor’s Degree, MBA preferred
- Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus)
- Strong industry involvement a plus
- Program Management skills
- Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
- Excellent communication skills both written and verbal
- Strong financial background
- CM Operational experience
- Experience quoting design and development activities.
- Experience building product cost models
- Self motivated
- Ability to plan and organize in ambiguous situations.
- Exceptional communication and problem solving skills
- Strong analytic skills
- Critical thinker
Process Engineer Technician
Provides tools and support to engineering and production while adhering to the quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed.
- Identifies, executes and promotes Continuous Improvement objectives
- Assists in defining Lean Manufacturing requirements
- Develop processes and procedures for projects to improve quality and cost
- Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
- Represent engineering for Material Review Board concerning material dispositions
- Represent Engineering in cross functional teams as assigned
- Maintain compliance to procedures and regulatory requirements
- Understand and follow safety policies and practices, attend safety training and wear PPE as required
- Maintains and prepares project plans to satisfy timeline requirements
- Prepares Engineering Change Orders for processes and components
- Performs Corrective and Preventative Action tasks
- Other Duties as assigned
- FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
- 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
- Experience with silicone molding is a plus
- Familiarity with Pro-E / CREO and or SolidWorks is preferred.
- Strong computer skills associated with Microsoft software
- Ability to interpret technical drawing, blueprints, specification and illustrations
- Must be able to read, write and speak fluent English.
- Excellent reading, writing, communication, and organizational skills.
- Demonstrated ability for systematic problem solving, DMAIC
- Maintains performance with changing priorities under minimal supervision
- Possess strong team collaboration skills
- Must be able to make clear and accurate decisions
- Strong desire to learn and apply new technology
- Associates degree in an Engineering discipline or related field
This job description in no way states or implies that these are the only duties to be performed by the employee in this position. Employee will be required to follow other job-related instructions and to perform other job-related duties requested by any person authorized to give instructions or assignments.APPLY NOW – email Careers@Cirtecmed.com
Swiss Machinist - Full Time, Monday - Thursday or Weekend Shift
The primary purpose of this job is to set up, operate and maintain CNC equipment to fabricate production parts.
Hours & Shifts:
- 1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
- 2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM
- Weekend shift is Friday – Sunday from 6:00 AM – 6:30 PM
- Operate and set up CNC shop equipment
- Make adjustments and monitor assigned equipment to ensure dimensional part integrity
- Able to preset tooling for setups and tool breakages during normal operations
- Maintain tooling following established tool life guide lines
- Troubleshoot and correct problem with minimal assistance
- Inspect parts visually and dimensionally using basic inspection equipment and techniques to assure conformance to requirements with minimal assistance
- Complete all applicable documentation for current operations
- Perform preventative machine maintenance as required
- Perform other functions as required
- 2-5 years machine shop experience in all phases of machining
- Ability to read, interpret and understand blueprints
- Ability to work with small precision parts to very close tolerances
- Ability to understand and follow through with verbal or written instructions
Deburrer needed to inspect parts for burrs, identify and remove burrs with speed and accuracy. To be a self-motivated individual with passion, integrity & commitment towards all work assignments. To produce the highest quality parts in the least amount of time.
- Identify all burrs on part & proficiently remove them with minimal errors
- Demonstrate the ability to read blueprints
- Safely use knives and other deburring tools
- Communicate effectively with team members
- Maintain good attendance
- Keep a clean and orderly work area
- Accurately record data on routers
- Ability to use general shop math
- Proficient use of a microscope at 20 power minimum
- One year experience working under microscope (at 20 power minimum)
- 6 months experience using knives and other deburring tools
Opportunities in Enfield, CT
Strategic Outsourcing Specialist
The Strategic Sourcing Specialist is responsible for the development and execution of sourcing strategies with a strong focus on new product introductions (NPI). Responsible for achieving best total value by leading the negotiations and supplier management with the company supply base, driving the strategic sourcing process and providing optimal supply assurance, including pricing, flexibility, quality and delivery performance.
- Builds and leverages strong working relationships with internal customers and key suppliers to assure cost, quality, and delivery targets are attained.
- As the primary supplier relationship owner, responsible for negotiating prices, terms and conditions, risk mitigations and warranties in support of those agreements.
- Communicate and implement strategies, contracts, and pricing with an overall focus on maintaining good supplier relationships and minimum total cost of ownership to achieve maximum advantage for the company and its customers.
- Develop key performance measures for chosen suppliers and negotiate on multiple variables to award longer-term strategic contracts that result in significant cost reductions and improved service levels.
- Analyze current spend and consolidate spend and researches, identifies, and analyzes current and emerging procurement trends.
- Support NPI programs by coordinating all sourcing and supplier qualification activities.
- Works closely with Finance to ensure proper segregation of duties with respect to Supply Chain.
- Creates policies and programs as needed to ensure compliance with Cirtec directives.
- Familiar with customs regulations for import of products from foreign countries.
- BA/BS and 5-7 years of work experience within the medical device industry strongly preferred.
- Extensive knowledge of supply chain planning, sourcing, inventory management, purchasing, logistics & experience in working with engineering and quality teams.
- Experience supporting NPI programs with quick turnaround time on quotes for accurate pricing on new business.
- Strong negotiation skills.
- Experience working with a medical device contract manufacturer desired.
Sr. Cost Accountant
The Senior Cost Accountant works closely with the CFO and Assistant Controller as the subject matter expert on all cost accounting activities for the company, ensuring an accurate representation of product and manufacturing costs and expenses on the company’ financial statements.
- Act as lead in establishing standard costs including labor and overhead rates, cost control systems, cost analysis and reporting.
- Identify, analyze, and report variances in product costing, job costing and production activities. Review labor and overhead application and variances.
- Collaborate with manufacturing, supply chain, and quality leaders with efforts to reduce costs, variances, customer returns, and manufacturing scrap.
- Perform monthly account reconciliations, analysis, and reporting for inventory, WIP, and variances. Also provide gross margin analysis per product line and customer.
- Provide support for year-end and other 3rd party audits of our inventory. This will include the identification of slow-moving and obsolete inventory, and communicate recommendations for the valuation and disposition of these items.
- Assist with the budgeting process for cost and product related valuations and estimates. Provide explanations of variances and deviations of the current budget to the actual results.
- Act as accounting representative in cross-functional teams to properly develop and execute cost and manufacturing transaction procedures to maximize the efficiency and use of our resources.
- Perform other related duties as assigned by management.
- Bachelor degree in accounting or related field.
- 10+ years’ experience in a manufacturing environment. Job shop/ batch manufacturing experience preferred.
- Excellent analytical and communication skills.
- High level skills with ERP systems, with experience in data queries and extraction.
- Advanced Excel skills.
- Must be self-motivated, and the ability to work independently with minimum supervision.
Process Development Engineer
Works in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
- Attends and arranges project meetings to discuss current and future design and development initiatives
- May serve as a primary contact with clients on projects of low to moderate complexity
- Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
- Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
- Responsible for the following project inputs:
- Feasibility builds, documentation, and testing
- Equipment selection
- Process development and documentation
- Device Verification samples and testing
- Operator training
- Process Failure Mode Effects Analysis
- Clinical builds
- Process Validation
- Involvement in the full design, development, and validation requirements of projects, including:
- Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
- Materials sourcing and device prototyping
- Design verification and validation activities, including data for regulatory submission
- Manufacturing transfer and support of existing product lines as applicable
- Other duties as assigned
- Willingness to travel, if required
- Must maintain high ethical standards
- Must demonstrate good organizational skills
- Must be able to read, write and speak fluent English
- A Bachelors degree in an engineering discipline and minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 4 years appropriate work experience; or a minimum 7 years relevant work experience; or equivalent.
- Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
- Strong computer skills, including the MS Office suite and MS Project
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
- Ability to learn and apply new technology
- Technical report preparation and formal presentation skills
- In house on the job training as required to meet job requirements
- Must remain current with trends and developments in the incumbent’s engineering specialty
- Decision Making and Problem Solving: Must be able to make clear and accurate decisions
- Analytical Problem Solving: Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions
- Interaction: Must be able to communicate well verbally and in writing and work well in a team environment
- Versatility: Able to respond to changing priorities with minimum disruption
- Initiative: Must be able to function with minimum supervision
- Leadership: Must be able to lead discussions, teams and meetings with customers and staff related to job role
Laser Technician - Levels I-IV - 2nd Shift
The Laser Technician has the general responsibility for operating laser and associated systems used in the manufacturing of products sold to our customers. The Technician III is expected to work with and assist in the training of lower level technicians to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position the Technician III will continue to build their skills with the upper level Technicians along with taking tasks and direction from the Engineering departments. In this position you must proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.
- Has the primary skills of operating manufacturing workstations including all laser systems used in the manufacture of products sold to our customers. (Unitech, Triumpf, Lasag, IPG)
- Perform laser welding, resistance welding laser marking, header pouring, silicone molding
- Glovebox laser welding
- Strong soldering experience. IPC 610 certification preferred
- Demonstrates strict adherence to all safety, GMP & quality system guidelines
- Proficient in the operation of computerized motion controllers
- Proficient, at an intermediate level, in modifying or creating computerized motion control programs
- Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions
- Working knowledge of drawings with an intermediate ability to interpret nomenclature and dimensions
- Must accurately document all work performed on inspection reports and travelers
- Performs in-process inspection of all parts and/or assemblies in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
- Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers.
- Provides direction within the manufacturing cell to Tech I or II associates assigned to assist them
- Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities
- Assist facilities departments and upper level Technicians in duties such as flash lamp or filter changes on lasers
- Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters
- Performs additional duties as required under the direction of the Production Team Leader or upper level Technicians
- Responsible for recognizing quality issues and communicating issues to the Qulaity and/ or Production Supervision
- Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures
- Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
- Assist Upper level Technicians or Engineers with parameter adjustments and weld parameter/process development.
- Ability to perform metallurgy (cross sections)
- Performs weld validations and collects data for validation reports
- Ability to provide input to Engineering and upper level Technicians in regards to tool design and/or troubleshooting processes
- Performs other job duties as assigned with little or no assistance or supervision
Experience & Education:
- Be able to read, write and speak fluent English
- High school diploma or General Education Degree (GED) is required
- Two to three years experience in a med device field preferred
- One year applications experience or equivalent training
- Strong experience with a variety of laser welding equipment and techniques
- Strong soldering skills (IPC 610 certification preferred)
- Header pouring, laser marking, silicone molding, glove box laser welding
- Moderate computer skills, including the MS Office suite
- Must be able to interpret technical drawings, blueprints, specifications & illustrations
- Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources
- Ability to learn and apply new technology
- Technical report preparation
- Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds
Technician II - 2nd Shift
A Technician II has the general responsibility for operating workstations and associated systems used in the manufacturing of products sold to our customers. The Technician II is expected to work with lower level Technicians and other upper level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.
- Has the primary function of operating workstations used in the manufacturing processes
- Proficient in set-up and loading component materials into product specific tools
- Has the responsibility of following established documentation for product manufacturing
- Demonstrates strict adherence to all safety, GMP & quality system guidelines
- Must accurately document all work performed on inspection reports and customer travelers
- Must have a general understanding of the CNC controlled workstations on the production floor
- Possesses the ability to read and follow process control documents, work instructions, and standard operating procedures
- Working knowledge of drawings, ability to interpret nomenclature and dimensions
- Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
- Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
- Provides direction within the manufacturing cell to Tech I associates assigned to assist them
- Ability to perform basic workstation set up and troubleshooting tasks
- Performs additional duties as required under the direction of the Production Manager
- Maintains cleanliness of work areas, machines, tools and equipment
- Assists Quality Control with inspection duties as required
- Responsible for recognizing quality issues and communicating these issues to quality and/ or Production Supervision
- Performs other job duties as assigned with minimal supervision
Opportunities in Los Gatos, CA
Document Control Administrator
The Document Control Administrator implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.
- Responsible for issuing part numbers, ECN #s.
- Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
- Responsible for making electronic changes to documents, release documents, and notifies affected departments.
- Responsible for maintaining related Document Control files.
- Responsible for ensuring documents are filed correctly and maintained per established procedures.
- Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
- Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
- Prepare reports and memorandums.
- Ensure Proper upkeep of technical documents.
- Coordinates Training program.
- Other duties as assigned.
- Extremely detail-oriented work habits.
- 1-2 years experience in the Medical Device Industry required.
- Flexible and motivated attitude.
- Advanced computer skills.
- Knowledge of document control procedures with data storage, maintenance, revision and archival background.
- Familiarity with FDA Quality System Regulation (QSR) and ISO 13485