Quality Engineer

JCW Group • Contract • Greater Minneapolis-St. Paul Area, US • $110,000 - $125,000 / year • 3d ago

Quality Assurance Engineer

Medical Device Northwest Minneapolis Metro | 6-Month Contract to Hire

We are seeking a Quality Assurance Engineer to provide operational quality input and deliverables across manufacturing programs throughout the product lifecycle. This role also supports development activities transitioning into commercial manufacturing, including manufacturing readiness, audits, and clinical builds, to ensure a smooth launch and continuously accurate and compliant Design History File. This is a 6-month contract to hire opportunity with the intent to bring the right candidate on permanently. This position does not offer visa sponsorship. Candidates must be authorized to work in the United States now and in the future without sponsorship.

Duties and Responsibilities

Document Control & Audit Readiness: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system
Data & Continuous Improvement: Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions
Incoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues
Equipment & Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes 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). Trend data and report findings at management review

Operations Quality 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 product Design History Files (DHF)
Advise project teams on best practices for quality and regulatory compliance
Own, review, and approve changes ensuring impacts and resulting actions are properly documented and executed
Receive, investigate, and document product complaints, interacting with customers as applicable
Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs
Drive Product Lifecycle Management (PLM) architecture and changes as needed

Qualifications

Bachelor's degree in a life science discipline or equivalent combination of education and experience
5+ years of experience in medical device development, or 3+ years in a Design Assurance or Quality Engineering role
Experience working within quality systems as defined in 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 product development and processes
Demonstrated technical expertise and leadership in quality
Strong attention to detail, organization, and accuracy
Creative problem-solving ability with a track record of proposing practical solutions
Strong written and verbal communication skills across disciplines and organizational levels
Demonstrated use of quality tools and methodologies including nonconformances, CAPAs, and root cause analysis
Experience with PLM software such as Windchill, Agile, or Propel
Intermediate to advanced proficiency in Microsoft Office Suite
Familiarity with statistical software such as Minitab preferred