Growing medical device OEM division of an industry leader in complex opto-mechanical capital equipment. The experienced Quality Systems Engineer in this key role reports to the company’s top QA manager and makes significant contributions to assuring the overall quality and regulatory compliance of Class II and II medical laser systems.
- Review, monitor and report performance of the quality management system, including KPIs.
- Participate in and represent QA in document and data control, quality planning, training, product recalls / advisory notices, incoming and final inspection.
- Participate in vendor selection, approval /qualification and monitoring processes. Follow-up on supplier issues, including notifications, corrective actions and supplier audits; maintain supplier files.
- Lead and facilitate MRB board activities including review and disposition of non-conforming materials.
- Provide analysis, support, follow-up, effectiveness verification and close out of CAPAs.
- Support creation of technical files and sign-off for relevant documentation.
- Participate in product design control activities for new and sustaining product development efforts, including documentation review and changes via formal change control.
- Support risk analysis activities, including hazard analyses, design and process FMEAs.
- Support Process/Design V&V activities, including software validation and IQ/OQ/PQ.
- Support Engineering in the creation, review and approval of DMR, DHR, routers, BOMs, and specifications for in- house and external manufacturing.
- Conduct internal audits of the Quality System; prepare for and participate in audits by FDA, ISO, etc.
- Lead equipment calibration.
Requirements and qualifications:
- BS in a biomedical, engineering, or scientific discipline.
- Five years minimum industrial experience in Medical Device Quality Assurance
- Experience performing internal quality and supplier audits to ISO 13485
- Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485, Health Canada MDDs, European MDRs.
- Experience with single-use and electro-mechanical capital equipment and single use devices manufactured in an ISO Class 7 controlled manufacturing environment.
- Experience with Arena is a plus.
- Experience working with medical device start-ups is a plus.