Job descriptionWe are looking for an experienced
Quality Engineer to lead supplier-side process validation and quality release activities for manufacturing transfers in a regulated environment. In this role, you will ensure production readiness by validating manufacturing processes, reviewing first-article inspections, and driving formal product release through established quality approval workflows.
You will work closely with engineering, supplier quality, and cross-functional teams to support successful product transfers while ensuring compliance with quality and regulatory standards.
Location Marysville, PA (On-site)
Key Responsibilities - Lead supplier production line validation activities using the APQP framework.
- Execute and document process validation activities (IQ/OQ/PQ) to ensure manufacturing readiness.
- Conduct and review First Article Inspections (FAI), evaluating inspection data against product specifications and quality requirements.
- Perform final quality verification and authorize the formal release of products to manufacturing.
- Create, manage, and maintain validation and inspection documentation within SAP QMS and quality management systems.
- Route quality documentation through cross-functional approval workflows.
- Perform on-site inspections at the manufacturing facility when required and coordinate results with Supplier Quality teams.
- Partner with engineering, supplier quality, and program teams to resolve quality issues and support manufacturing transfers.
- Ensure compliance with applicable quality standards, procedures, and regulatory requirements.
Required Qualifications - Bachelor's degree in Mechanical, Industrial, Biomedical, Electrical Engineering, or a related engineering discipline.
- 9-12 years of experience in Quality Engineering within the medical device or another highly regulated manufacturing environment.
- Strong knowledge of ISO 13485 quality management systems.
- Proven experience with APQP, PPAP, and process validation (IQ/OQ/PQ).
- Hands-on ownership of First Article Inspection (FAI), including technical review and evaluation of inspection data.
- Experience working directly with manufacturing suppliers and driving quality approvals.
- Experience creating and managing quality documentation in SAP QMS or similar quality management systems.
- Excellent communication and cross-functional collaboration skills.
Preferred Qualifications - Experience with CPAP, ventilation, respiratory, or life-support medical devices.
- Experience supporting manufacturing transfers or New Product Introduction (NPI) into production.
- Familiarity with supplier quality management and production readiness activities in regulated environments.
