Senior Quality Engineer

Senior Quality Engineer (CAPA / QMS Focus)

Location: Twin Cities, MN

Full-time | Onsite

We are seeking an experienced and detail-oriented Senior Quality Engineer to drive continuous improvement across our Quality Management System (QMS). This role will lead and manage Corrective and Preventive Actions (CAPAs), oversee Nonconformance Reports (NCRs), conduct in-depth root cause analyses, and ensure ongoing compliance with regulatory and internal quality standards.

This role requires a highly hands‑on, self‑directed engineer comfortable managing multiple CAPAs simultaneously in a small‑team environment, with experience in complaint investigations, NCMR processes, and supporting quality activities for clinical‑stage or Class II/III medical devices (PMA experience a plus).

• Lead end‑to‑end CAPA processes, including initiation, investigation, implementation, and effectiveness verification
• Ensure timely closure of CAPAs in compliance with internal procedures and regulatory requirements
• Identify systemic issues and recommend preventative actions across the organization
• Track and trend CAPA data to drive continuous improvement initiatives

• Review, disposition, and manage Nonconformance Reports (NCRs)
• Collaborate cross‑functionally to assess impact and determine appropriate actions
• Ensure accurate documentation and traceability of nonconformance handling
• Analyze NCR trends to identify recurring issues and improvement opportunities

• Conduct and facilitate structured root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree Analysis)
• Drive cross‑functional problem‑solving efforts for complex quality issues
• Ensure root cause identification is data‑driven, thorough, and sustainable
• Coach teams on effective problem‑solving methodologies

• Support the development, implementation, and continuous improvement of the QMS
• Ensure compliance with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry‑specific regulations)
• Lead internal audits and support external regulatory audits and inspections
• Maintain and improve quality procedures, work instructions, and documentation
• Monitor key quality metrics and report on system effectiveness

• Drive initiatives that improve product quality, reduce defects, and enhance process efficiency
• Utilize data analysis and quality tools (e.g., SPC, Pareto analysis) to identify improvement areas
• Partner with engineering, manufacturing, and operations teams to implement solutions

• Bachelor's degree in Engineering, Quality, or related technical field
• 5-8+ years of Quality Engineering experience in a regulated industry (e.g., medical device, aerospace, manufacturing)
• Deep experience with CAPA and NCR systems
• Strong expertise in root cause analysis methodologies
• Hands‑on experience maintaining and improving a Quality Management System (QMS)
• Working knowledge of relevant industry standards (ISO, FDA, or equivalent)
• Excellent problem‑solving, analytical, and organizational skills

• ASQ certifications (e.g., CQE, CQA)
• Experience with electronic QMS (eQMS) platforms
• Lean Six Sigma (Green Belt or Black Belt)
• Experience supporting audits and regulatory inspections

• Structured problem‑solving and investigative mindset
• Strong attention to detail and documentation discipline
• Ability to influence cross‑functional teams
• Data‑driven decision‑making
• Continuous improvement orientation

• Opportunity to shape and strengthen quality systems at a strategic level
• High visibility role with cross‑functional collaboration
• Dynamic environment focused on innovation and excellence

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.