Senior Quality Assurance Engineer

Nextern•Maple Grove, MN

About The Position

This role 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.

Requirements

Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
Development project team member on complex medical device development programs, including systems
Understanding of ISO 14971 and application of risk management to product development and processes.
Demonstrated technical expertise and leadership in quality.
High attention to detail, organization, and accuracy.
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
Demonstrated 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)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Nice To Haves

Familiarity with statistical software, such as Minitab, preferred.

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: Act 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, and approve product and engineering work orders. Create and maintain up-to-date product Design History Files (DHF). Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance. Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) 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.