Quality Systems Manager – Medical Device Manufacturing

Weiss-Aug MedPharma•Fairfield, NJ

5d•Onsite

About The Position

Weiss-Aug is a leading provider of advanced manufacturing and engineering solutions with over 50 years of experience. They specialize in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions. Their Weiss-Aug MedPharma division serves the medical device and life science industry, offering vertically integrated manufacturing solutions and in-house product design and engineering services. The company is expanding its team to enhance solution offerings, drive new growth, and support its technology roadmap, including advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing. They are seeking a passionate and skilled Quality Systems Manager to lead, maintain, and continuously improve their 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 experienced in implementing ISO 13485 certification and managing FDA Establishment Registration and device listing activities. The Quality Systems Manager will be the primary owner of QMS compliance, internal/external audits, and regulatory readiness, ensuring operations meet high standards of safety, quality, and reliability.

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.

Nice To Haves

Experience in injection molding, assembly, machining, or other precision manufacturing environments.
ASQ certifications (CQE, CQA, CMQ/OE) or equivalent.
Familiarity with electronic QMS platforms.

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.