Staff Quality Engineer at Plexus in Louisville CO
Company: Plexus
Position: Staff Quality Engineer (Auto Req id 10911BR)
Location: Louisville, CO (Boulder CO)
Job Description:
The Quality Engineer for Medical Device Development will serve as the focal point for the project team and the customer on topics related to safety agency and regulatory compliance as well as the necessary quality system(s).
The Quality Engineer has overall responsibility for assuring that the product is designed and tested in compliance with applicable domestic and international regulatory agencies and/or bodies.
This includes but is not limited to:
- Participating in the development of the product specifications,
- Defining project compliance to internal and external standards,
- Coordinating safety agency marking and regulatory compliance,
- Coordinating the risk management and human factors activities,
- Coordinating design verification test activities.
Key Aspects of your Job:
- Ensure that the planned project activities are compliant with Plexus’ standard operating procedures and ISO (i.e. 13485) quality systems, the FDA Quality System Regulation (QSR) regulations.
- Understand Design History File (DHF) content requirements and be capable of performing all aspects of DHF maintenance.
- Support proposal activities for new business and other marketing support as requested.
- Participate in the Plexus quality system development and maintenance.
- Understand medical device safety standards (i.e. IEC 60601-1), regulatory requirements, and be capable of identifying those that are applicable for each unique product.
- Determine appropriate specifications to comply with regulatory and compliance requirements of intended markets.
- Mentor and lead the project team on regulatory and safety agency compliance requirements of intended markets.
- Facilitate documentation of functional, electrical and mechanical specifications.
- Lead the development of the product Risk Management Plan and maintain customer specified content of the Risk Management File for each unique product.
- Lead product Risk Analysis meetings and document the results as specified in ISO 14971. Follow up as required throughout the project to ensure adherence to risk management plan. Risk activities also include coordination of Design Failure Modes and Effect Analysis reports, Fault Tree Analysis, and other risk reports.
- Coordinate device reviews with safety agencies.
- Coordinate all Design Verification Test activities, including generation of the verification Plan, Procedures and Report documents.
- Review design related project documents and drawings to ensure internal and external requirements are met.
- Participate in engineering reviews to ensure they are conducted and documented as appropriate.
What you need to be Successful in your Job:
- Possess a strong working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1)
- Possess understanding of regulatory requirements such as FDA Quality System Regulations, ISO 13485 and the EU Medical Device and In Vitro Diagnostic Medical Device Directives
- Experience with the development of risk management planning and analysis as defined in ISO 14971
- Experience with Design Verification Test activities including test planning, test procedure and test report development
- Experience working with safety agency test labs for agency certifications such as UL, CSA, CE, etc.
- Possess at least basic knowledge of the Software Quality Engineering functions
- Possess excellent verbal and written communication skills as well as interpersonal skills necessary to work across multiple engineering disciplines, project management, and external customers.
- Must be able to work in a matrix style organization on multiple projects simultaneously.
Education & Experience
- A Bachelor’s degree in a scientific, engineering or equivalent background is required for this position
- Experience of 8 years in quality engineering for medical device
product development or equivalent is required for this position
For more detail and to apply go to Plexus Boulder CO Jobs web page
then search via Auto Req ID 10911BR
