Sr. Quality Assurance Engineer

Nextern•Maple Grove, MN

About The Position

At Nextern, the Sr. Quality Assurance Engineer provides operational quality input and deliverables for manufacturing programs throughout the product lifecycle. The role also supports development activities preparing for commercial manufacturing, including manufacturing readiness, audits, and clinical builds, helping ensure a smooth transition and an accurate, compliant Design History File (DHF). The engineer supports compliance with the Quality System and applicable regulations and standards, continuous improvement, and professional interaction with Nextern customers as needed. The role serves as a quality point of contact for production and advises project teams on quality and regulatory compliance.

Requirements

Bachelor's degree in a life science discipline, or an equivalent combination of education and experience.
At least 5 years of experience in a Quality Assurance role in a medical device development environment.
Experience working with quality systems defined by 21 CFR 820 and ISO 13485.
Experience as a development project team member on complex medical device development programs, including systems.
Understanding of ISO 14971 and the application of risk management to product development and processes.
Demonstrated technical expertise and leadership in quality.
High attention to detail, organization, and accuracy.
Ability to think creatively and propose novel solutions.
Strong written and verbal communication skills across disciplines and organizational structures.
Demonstrated use of quality tools and methodologies, such as nonconformance management, CAPAs, and root cause analysis.
Experience with Product Lifecycle Management (PLM) software, such as Windchill, Agile, or Propel.
Intermediate to advanced proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, Project, and Outlook.

Nice To Haves

Familiarity with statistical software such as Minitab.

Responsibilities

Author and approve SOPs, work instructions, and forms.
Support internal audits and maintain inspection readiness across the quality system.
Compile and trend quality metrics, identify systemic issues, present actionable insights to leadership, and drive corrective and preventive actions.
Oversee incoming inspection according to approved sampling plans.
Disposition nonconforming materials and coordinate supplier corrective actions for recurring quality issues.
Provide quality oversight for IQ/OQ/PQ qualification activities and review and approve protocols, reports, and change orders.
Evaluate the regulatory impact of equipment changes before implementation.
Manage nonconformances and CAPAs from initiation through effectiveness verification.
Lead root cause analysis using structured methods such as 5-Why and fishbone analysis.
Trend data and report findings at management review.
Serve as the quality point of contact for production; review batch records and travelers for GMP compliance; and 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 and lead by example in quality and regulatory compliance best practices.
Own, review, and approve changes, ensuring impacts and resulting actions or lack of action are documented and executed appropriately.
Receive, investigate, and document product complaints, interacting with customers as applicable.
Support audits as a subject matter expert for QMS processes and product DHFs.
Drive Product Lifecycle Management (PLM) architecture and changes as needed.