Quality Systems Manager

Quality Manager Needed For Leading Medical Device Company
This Jobot Job is hosted by: Kevin Finlay

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A bit about us:
My client is a leading Medical Device Manufacturer and are growing! They are looking to add a Quality Systems Manager who will be responsible 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.

Why join us?
Other Benefits Include

• 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

Job Details
Responsibilities:

• 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.
• Serve as the primary point of contact for regulatory bodies, notified bodies, and customer quality audits.
• Manage core QMS processes including: document control, CAPA, nonconformance management, supplier quality, internal audits, training systems, and risk management (ISO 14971).
• Lead cross-functional teams to investigate quality issues, implement corrective actions, and drive continuous improvement.
• Ensure manufacturing processes remain validated, controlled, and compliant with regulatory expectations.
• Develop and deliver quality training across the organization to strengthen quality culture and compliance awareness.
• Prepare and present quality metrics, audit findings, and compliance status to senior leadership

Requirements:

• Bachelor’s degree in Engineering, Quality, or related field.