Quality Systems Manager Medical Device Manufacturing

Quality Systems Manager - Medical Device Manufacturing Weiss-Aug MedPharma - 3.2 Fairfield, NJ Job Details Full-time 8 hours ago Benefits Health savings account Disability insurance Health insurance Dental insurance Flexible spending account Tuition reimbursement Smoking cessation program Employee assistance program Vision insurance 401(k) matching Pet insurance Qualifications Regulatory compliance ISO certification audits Quality control audit Manufacturing facility Medical device manufacturing facility experience Auditing experience within manufacturing industry Leading team collaboration initiatives Biomedical regulatory compliance Manufacturing Cross-functional team management Cross-functional communication FDA regulations

Full Job Description Description:

Join Weiss-Aug - A Leader in Precision Manufacturing and Innovation Be part of a company that's shaping the future of manufacturing where your ideas, skills, and passion matter. Weiss-Aug, is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years. Why Join Us? At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions our Weiss-Aug MedPharma serves the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services. These combined capabilities provide Weiss-Aug a strategic advantage over the competition, being able to offer our customers a true, single-source supplier option, to meet their most challenging product innovation needs. As we continue to push the boundaries of what is possible, including our latest advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies - Weiss-Aug MedPharma needs the best minds in industry. Expanding our team is paramount, bringing in fresh perspectives, ideas and broad-based talent to further enhance our solution offerings, driving new growth and supporting our technology roadmap - including the release of finished drug-delivery / combination devices and machined implants. We're currently seeking a passionate and skilled Quality Systems Manager - Medical Device Manufacturing to join our team and contribute to our mission of delivering high-quality, engineered solutions to our customers worldwide. In this role you 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. 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. 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. Excellent communication, documentation, and cross-functional leadership skills. Preferred Qualifications Experience in injection molding, assembly, machining, or other precision manufacturing environments. ASQ certifications (CQE, CQA, CMQ/OE) or equivalent. Familiarity with electronic QMS platforms. This position is at our Fairfield, NJ location.

Pay Range:

$ 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 US Pay Transparency The base salary for this role will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, experience, and internal consistency. If your salary requirements exceed the advertised range and you remain interested in Weiss-Aug, we encourage you to apply. Weiss-Aug is an Equal Opportunity/Affirmative Action Employer. Applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other characteristics protected by applicable federal, state, or local law.