Sr. Quality Assurance Engineer

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide. The Sr;. Quality Assurance Engineer is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers. RESPONSIBILITIES: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality systemCompile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actionsOversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issuesProvide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementationManage 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 reviewAct 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, and approve product and engineering work ordersCreate and maintain up-to-date product Design History Files (DHF)Advise project teams and lead by example in best-practices for Quality and Regulatory ComplianceOwn, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) 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 needed Requirements Required: Bachelor's Degree (BS) in a STEM related field5+ years of experience in a Design Assurance or Quality Engineering role in the medical device industryExperience working in quality systems as defined in 21 CFR 820 and ISO 13485Development project team member on complex medical device development programs, including systemsUnderstanding of ISO 14971 and application of risk management to product development and processesDemonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..)Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)Demonstrated technical expertise and leadership in qualityHigh attention to detail, organization, and accuracyInstinctual capability for creative thinking and proposing novel solutionsStrong ability to communicate (written and verbally) within and across disciplines and organization structuresIntermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook) Preferred: Familiarity with statistical software, such as Minitab, preferred Salary Range: $100,000 to $125,000 based on skills and experience Benefits Health Care Plan (Medical, Dental & Vision)Retirement Plan with Company MatchPaid Time Off, Personal Days, AND Birthday Holiday!Lifetime Membership Subsidy and Wellness ResourcesLife Insurance (Basic, Voluntary & AD&D)MN Paid Leave Short-Term & Long-Term DisabilityTaco Thursdays!!! Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.