Quality Engineer

Quality Assurance Engineer – Medical Device

*Direct Hire*

About the Opportunity

We are looking for a Quality Assurance Engineer to become a core part of a contract manufacturing medical device organization. This is a permanent role for someone who wants to plant roots, build something, and grow with a team. You will provide operational quality input across manufacturing programs throughout the product lifecycle while supporting development activities as they transition into commercial manufacturing — including manufacturing readiness, audits, and clinical builds — ensuring a compliant and accurate Design History File from day one.

What You'll Own

• Document Control & Audit Readiness

— Author and approve SOPs, work instructions, and forms. Maintain inspection readiness and support internal and external audits across the quality system

• Data & Continuous Improvement

— Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive CAPA implementation

• Incoming Inspection & Supplier Quality

— Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions

• Equipment & Process Oversight

— Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact prior to implementation

• NC & CAPA Leadership

— Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone) and report findings at management review

Day-to-Day Operations Support

• Serve as the quality point of contact for production


• Review batch records and travelers for GMP compliance


• Support line clearances, first-article inspections, and process change reviews


• Draft, collaborate on, and approve product and engineering work orders


• Create and maintain up-to-date Design History Files (DHF)


• Advise project teams on quality and regulatory best practices


• Receive, investigate, and document product complaints, interacting with customers as applicable


• Support audits as SME for QMS processes and product DHFs


• Drive PLM architecture and changes as needed

What We're Looking For

• Bachelor's degree in a life science discipline or equivalent experience


• 5+ years in medical device development, or 3+ years in a Design Assurance or Quality Engineering role


• Working knowledge of 21 CFR 820 and ISO 13485


• Background as a development project team member on complex medical device programs, including systems-level work


• Understanding of ISO 14971 and application of risk management to products and processes


• Demonstrated technical leadership in quality with strong attention to detail


• Strong written and verbal communication skills across disciplines and organizational levels


• Experience with PLM software such as Windchill, Agile, or Propel


• Intermediate to advanced Microsoft Office proficiency


• Familiarity with Minitab or similar statistical software preferred