Quality Systems Manager – Medical Device Manufacturing
About the role
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?
- Driven by a commitment to excellence, innovation, and continuous improvement.
- A recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions.
- Serving the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services.
- Offering 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.
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.
Location
This position is at our Fairfield, NJ location.
Benefits
- 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