Senior Quality Assurance Engineer

Nextern; Osseo (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental & Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND Birthday Holiday!

Lifetime Membership Subsidy and Wellness Resources

Life Insurance (Basic, Voluntary & AD&D)

MN Paid Leave

Short-Term & Long-Term Disability

Job summary

Nextern, located in Osseo, Minnesota, seeks a Quality Assurance Engineer responsible for ensuring operational quality throughout the product lifecycle. The role involves documenting processes, managing nonconformances, and supporting compliance with regulatory standards. Candidates should have a Bachelor's Degree in life sciences and significant experience in medical device development. Benefits include health care plans, retirement matching, and a commitment to diversity in hiring.

Qualifications

• 5+ years of experience in medical device development, or 3+ years in Design Assurance or Quality Engineering.
• Experience with quality systems defined in 21 CFR 820 and ISO 13485.
• Demonstrated use of quality tools and methodologies.

Responsibilities

• Document Control: Author and approve SOPs, work instructions, and forms.
• Compile and trend quality metrics to identify issues.
• Oversee incoming inspections and manage nonconformances.

Skills

Quality engineering

Risk management

Creative thinking

Communication

Attention to detail

Education

Bachelor's Degree in life science discipline

Tools

Minitab

MS Office Suite

Product Lifecycle Management (PLM) software

Job description

SUMMARY: 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.

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:
• 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.

Supervisory Responsibilities

This job has no direct supervisory responsibility.

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..).
• Familiarity with statistical software, such as Minitab, preferred.
• 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).

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• MN Paid Leave
• Short-Term & Long-Term Disability

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.