Quality Engineer II

4 weeks ago

Minneapolis, United States Nudmeen Global ltd Full time

We are seeking an experienced Quality Engineer to lead compliance and quality assurance initiatives for a well‑established, mid‑sized Medical Device manufacturer in the Twin Cities (Medical Alley). This company is focused on innovation in critical Class II/III devices and needs a professional to ensure their systems scale effectively with their growth. Who We Are We are specialist recruiters dedicated exclusively to the Medical Device Industry in Minnesota. We focus on supplying top talent in Quality Assurance, Compliance, and Validation across the Twin Cities metro. We meticulously match candidates to roles, ensuring your experience and career goals align perfectly with the client’s needs and requirements. Your Key Responsibilities: Quality Systems Ownership: Lead the implementation and improvement of core Quality Systems, focusing heavily on CAPA (Corrective and Preventive Action) effectiveness and process controls. Regulatory Compliance: Act as a subject matter expert, ensuring strict adherence to global standards, including FDA QSR, ISO 13485, and ISO 14971 compliance. Documentation & DHF: Support the creation and maintenance of essential regulatory documentation, including elements of the Design History File (DHF) and Risk Management documents. Project Leadership: Drive quality‑related projects to timely completion, working effectively across engineering, manufacturing, and R&D functions. Audit Support: Play a key role in preparing for and supporting external regulatory body audits. What Makes You a Great Fit Minimum 2‑5 years of Quality Engineering experience, with strong exposure to Class II or Class III Medical Devices. Detailed, demonstrable knowledge of FDA, GMP, ISO 13485, and ISO 14971 is essential. Proven ability to manage and resolve complex CAPA projects. Strong written and verbal communication skills, with the ability to lead and motivate cross‑functional teams. Bachelor’s degree in Engineering, Technical Field, or equivalent. ASQ CQE Certification is highly valued. The Opportunity & Next Steps: Join a company where your contributions are highly visible and truly make a difference in patient care. This organization offers a competitive compensation structure, a highly collaborative team environment, and the chance to rapidly expand your career responsibilities. If you are a driven Quality Systems expert seeking impact and growth within the Medical Alley community, send your detailed CV/resume to info@nudmeenltd.com to engage with a specialized recruiter who will match you carefully to this role Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Staffing and Recruiting Get notified about new Quality Engineer jobs in Minneapolis, MN. #J-18808-Ljbffr

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