Job Description: Quality Manager – Medical Devices 

Location: Minneapolis-St. Paul, MN
Industry: Medical Device Manufacturing
Reports to: Director of Quality / QA Manager

We are an established and growing medical device manufacturer headquartered in the Minneapolis-St. Paul area, known for our commitment to patient safety, innovation, and high-quality standards. Our team designs and produces Class II and Class III medical devices that make a meaningful difference in healthcare outcomes. With a strong focus on regulatory compliance, operational excellence, and cross-functional collaboration, we offer a dynamic and purpose-driven work environment where quality is at the heart of everything we do.

Job Summary

We are seeking a highly motivated Quality Manager to lead and oversee our quality assurance and compliance programs in the development and manufacturing of medical devices. The ideal candidate will ensure compliance with FDA regulations, ISO 13485 standards, and internal quality policies while driving continuous improvement initiatives.

Key Responsibilities

• Manage and maintain the Quality Management System (QMS) in accordance with FDA 21 CFR Part 820 and ISO 13485.

• Lead internal and external quality audits, including FDA inspections and supplier audits.

• Oversee CAPA (Corrective and Preventive Actions) processes and ensure timely resolution.

• Collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Supply Chain teams to ensure product quality and regulatory compliance.

• Analyze quality data, trends, and metrics to identify opportunities for process improvement.

• Develop, review, and update quality documentation (SOPs, work instructions, validation protocols).

• Lead and mentor quality assurance staff and foster a culture of quality and compliance.

• Support new product introductions from a quality and compliance perspective.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field preferred.

• 5+ years of experience in quality management within the medical device industry.

• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and GMP.

• Experience managing CAPA, audits, and supplier quality management.

• Certifications such as CQE (Certified Quality Engineer), CQA, or Six Sigma preferred.

• Excellent leadership, communication, and problem-solving skills.

• Detail-oriented with strong organizational abilities.

Benefits

• Base Salary: $90,000 – $140,000 per year based off experience

• Benefits: Health insurance, 401(k), paid time off, Flexible Schedule, Work/Life Balance

• Potential Hybrid