Quality Systems Manager – Medical Device Manufacturing

Join Weiss-Aug as a Quality Systems Manager – Medical Device Manufacturing to lead, maintain, and continuously improve our Quality Management System (QMS) in alignment with ISO 13485, 21 CFR Part 820, and global medical device regulatory expectations. This role is ideal for a hands-on, detail-driven quality leader who has successfully implemented ISO 13485 certification and managed FDA Establishment Registration and device listing activities for manufacturing sites.

What You Will Do

Lead, maintain, and enhance the company’s ISO 13485–compliant Quality Management System, ensuring alignment with FDA QSR and applicable global regulations. Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.

Why It Might Be a Fit

The Quality Systems Manager will serve as the site’s primary owner of QMS compliance, internal/external audits, and regulatory readiness, ensuring that our operations meet the highest standards of safety, quality, and reliability.

Requirements

• Bachelor’s degree in Engineering, Quality, or related field.
• 10+ years of experience in medical device manufacturing quality systems, with direct ownership of QMS processes.
• Demonstrated experience implementing ISO 13485 and successfully achieving certification.
• Hands-on experience completing FDA Establishment Registration
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and applicable regulatory guidance.
• Proven success leading internal and external audits.
• Excellent communication, documentation, and cross-functional leadership skills.

Benefits

• Medical, Dental and Vision
• 401 (k) with company match
• Holiday, Vacation and Sick Time
• Tuition Reimbursement
• Health Savings Accounts (HAS)
• Flexible Spending Accounts (FSA)
• Cigna Wellness Incentive Program
• Employee Assistance Program (EAP)
• Short Term Disability
• Group Life and Accidental Insurance
• Sun Life – Accident, Critical Illness, and Hospital Indemnity Insurance
• Smoking Cessation Program
• Pet Insurance