Quality Engineer

JCW Group; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

JCW Group in Minneapolis is seeking a Quality Assurance Engineer specializing in medical devices. In this role, you will oversee quality processes, ensure compliance with regulatory standards, and support operational quality across manufacturing programs.

The ideal candidate has a Bachelor's degree in life sciences and at least 5 years of relevant experience. This permanent position offers a chance to grow with the organization and contribute to the success of medical device initiatives.

Qualifications

• 5+ years in medical device development, or 3+ years in Design Assurance or Quality Engineering role.
• Working knowledge of 21 CFR 820 and ISO 13485.
• Demonstrated technical leadership in quality with strong attention to detail.

Responsibilities

• Provide quality oversight for IQ/OQ/PQ qualification activities.
• Compile and trend quality metrics to identify systemic issues.
• Serve as the quality point of contact for production.

Skills

Document Control & Audit Readiness

Data & Continuous Improvement

Incoming Inspection & Supplier Quality

Equipment & Process Oversight

NC & CAPA Leadership

Education

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

Tools

PLM software (e.g., Windchill, Agile, Propel)

Minitab

Microsoft Office

Job description

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