Quality Assurance Engineer

Quality Assurance Engineer - Medical DeviceNorthwest Minneapolis Metro | 6-Month Contract to HirePosition OverviewWe 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 ResponsibilitiesDocument Control & Audit Readiness: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality systemData & Continuous Improvement: Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actionsIncoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issuesEquipment & 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 implementationNC & 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 reviewOperations Quality Support:Serve as the quality point of contact for productionReview batch records and travelers for GMP complianceSupport line clearances, first-article inspections, and process change reviewsDraft, collaborate on, and approve product and engineering work ordersCreate and maintain up-to-date product Design History Files (DHF)Advise project teams on best practices for quality and regulatory complianceOwn, review, and approve changes ensuring impacts and resulting actions are properly documented and executedReceive, investigate, and document product complaints, interacting with customers as applicableSupport audits as Subject Matter Expert (SME) for QMS processes and product DHFsDrive Product Lifecycle Management (PLM) architecture and changes as neededQualificationsBachelor's degree in a life science discipline or equivalent combination of education and experience5+ years of experience in medical device development, or 3+ years in a Design Assurance or Quality Engineering roleExperience working within quality systems as defined in 21 CFR 820 and ISO 13485Background as a development project team member on complex medical device programs, including systems-level workUnderstanding of ISO 14971 and application of risk management to product development and processesDemonstrated technical expertise and leadership in qualityStrong attention to detail, organization, and accuracyCreative problem-solving ability with a track record of proposing practical solutionsStrong written and verbal communication skills across disciplines and organizational levelsDemonstrated use of quality tools and methodologies including nonconformances, CAPAs, and root cause analysisExperience with PLM software such as Windchill, Agile, or PropelIntermediate to advanced proficiency in Microsoft Office SuiteFamiliarity with statistical software such as Minitab preferred