Job Type
Full-time
Description
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.
