Experience: Senior Level
Salary: $130,000 - $160,000 per year
Job Details
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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.
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.
A bit about us:
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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?
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Compensation Up To $160,000
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
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