Quality Systems Manager

Quality Systems Manager $130,000 - $160,000 per year | Parsippany, NJ | On‑Site | Permanent We are a leading medical device manufacturer seeking a Quality Systems Manager 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. Benefits Medical, Dental, and Vision 401(k) with company match Holiday, Vacation, and Sick Time Tuition Reimbursement Health Savings Accounts (HSA) 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 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 a 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. EEO Statement Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. #J-18808-Ljbffr