Supplier Quality Engineer (Medical Devices)

TL;DR

Supplier Quality Engineer (Medical Devices): Leading supplier-side process validation and quality release for manufacturing transfers in a regulated environment with an accent on APQP, IQ/OQ/PQ, and FAI. Focus on ensuring production readiness and regulatory compliance within ISO 13485 standards.

Location: On-site in Marysville, PA

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across Life Sciences and Engineering domains.

What you will do

• Lead supplier production line validation activities using the APQP framework.
• Execute and document process validation (IQ/OQ/PQ) to ensure manufacturing readiness.
• Conduct and review First Article Inspections (FAI), evaluating data against product specifications.
• Manage and route quality documentation through approval workflows within SAP QMS.
• Partner with engineering and program teams to resolve quality issues during manufacturing transfers.
• Ensure strict compliance with applicable quality standards and regulatory requirements.

Requirements

• Bachelor's degree in Mechanical, Industrial, Biomedical, Electrical Engineering, or a related field.
• 9–12 years of experience in Quality Engineering within medical device or highly regulated manufacturing.
• Strong knowledge of ISO 13485 quality management systems.
• Proven expertise in APQP, PPAP, and process validation (IQ/OQ/PQ).
• Hands-on experience with First Article Inspection (FAI) and SAP QMS.
• Must be based in Marysville, PA for on-site work.

Nice to have

• Experience with CPAP, ventilation, respiratory, or life-support medical devices.
• Experience supporting manufacturing transfers or New Product Introduction (NPI).
• Familiarity with general supplier quality management in regulated environments.

Culture & Benefits

• International community representing more than 110 nationalities.
• High internal growth potential, with 70% of leaders starting at entry level.
• Access to a strong internal Academy with over 250 training modules.
• Dynamic work environment with frequent team-building events and after-works.

Hiring process

• Brief virtual or phone introductory call to align motivations.
• Average of three interviews with line managers and future colleagues.
• Technical assessment or case study depending on the specific requirements.