Senior Quality Assurance Engineer

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.

Qualifications

• 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 Suite (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
• Taco Thursdays!!!