Job Description
Quality Manager Needed For Leading Medical Device Company This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary:
$130,000 - $160,000 per year 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? 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 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. 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. Interested in hearing more? Easy Apply now by clicking the "Apply Now" button. 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 (40 and over), 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. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy
