Sr. Product Quality Engineer
The Sr. Product Quality Engineer will support and guide the development, implementation, and management of the design quality engineering principles to comply with Quality Management Systems of ISO 13485 and FDA QSR. The Sr. Product Quality Engineer will demonstrate a high level of individual subject matter expertise, responsibility and accountability.
- Act as the core team member and design control system subject matter expert.
- Guide the team through out the design control system stage gate process. Identifying and explaining the key deliverables, review of deliverable documentation, making meaningful comments,
- Must be familiar and experience using/implementing the IEC 62304 software development lifecycle, IEC 62366 usability standard, ISO 14971 risk management and other applicable standards.
- Lead the risk management activities according to the industry standard, ISO14971. Also, lead the failure mode and effect analysis with cross functional teams.
- Sound statistical principles and practices.
- Must be familiar with the product lifecycle development from the requirements gathering to product end of life.
- Collaborate with the cross-functional team regarding all the product change management throughout the lifecycle.
- Update, review and develop Quality Management System standard operating procedures and supporting work instructions per ISO 13485 and FDA QSR as and when required.
- Must be an active participant in validations and verifications required through the design control system. Able to write protocols and reports where quality is the primary owner.
- New product introduction to manufacturing including IQ/OQ/PQ.
- Train other core team personnel, as applicable, in use of quality systems, tools, and techniques based on ISO 13485 and FDA QSR.
Education and/or Experience
- BS in a STEM field required; Molecular Biology, Engineering, or related discipline strongly preferred.
- Minimum of six years’ experience in a FDA regulated Medical Device industry required; Diagnostics experience preferred.
- Professional certification in Quality Auditing, Quality Engineering, and/or Quality Management preferred.
- Proactive approach, with high sense of urgency and results orientation.
- Strong interpersonal skills, demonstrated ability to interface effectively on project teams.
- High levels of integrity, honesty and maturity.
- Statistical tools, PLM software applications, AQL standards, workmanship and quality standards.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.