Supplier Quality Engineer

Amaris Consulting; Marysville (WA); On-site; USD 95,000 - 150,000; Full time

Job summary

Amaris Consulting seeks an experienced Quality Engineer to lead supplier-side validation and quality release for manufacturing transfers in a regulated environment. You will validate processes, review FAI data, and drive product releases through quality workflows.

This on-site role in Marysville, PA requires deep APQP, PPAP, and IQ/OQ/PQ expertise and hands-on FAI ownership, with collaboration across engineering and supplier quality teams to ensure manufacturing readiness and regulatory

Qualifications

• Bachelor's degree in an engineering discipline required.
• 9–12 years of experience in Quality Engineering within medical device or regulated manufacturing.
• Strong knowledge of ISO 13485 quality management systems.
• Experience with APQP, PPAP, and process validation (IQ/OQ/PQ).
• Hands-on ownership of First Article Inspection (FAI).
• Experience working with manufacturing suppliers and driving quality approvals.
• Experience creating and managing quality documentation in SAP QMS or similar systems.
• Excellent communication and cross-functional collaboration skills.

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) and evaluate inspection data against specifications.
• Perform final quality verification and authorize formal release of products to manufacturing.
• Create, manage, and maintain validation and inspection documentation in SAP QMS and quality systems.
• Route quality documentation through cross-functional approval workflows.
• Perform on-site inspections at the manufacturing facility and coordinate results with Supplier Quality teams.
• Collaborate with engineering, supplier quality, and program teams to resolve quality issues and support transfers.
• Ensure compliance with applicable quality standards, procedures, and regulatory requirements.

Education

Bachelor's degree in Mechanical, Industrial, Biomedical, Electrical Engineering

Tools

SAP QMS

Job description

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.

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

• College 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.

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.