Supplier Quality Engineer

Location: Marysville, PA (On-site)

About the role

We 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.

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.

Requirements

• 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.

Benefits

• An international community bringing together more than 110 different nationalities.
• An environment where trust is central: 70% of our leaders started their careers at the entry level.
• A strong training system with our internal Academy and more than 250 modules available.
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.).