Quality Systems Manager

Guided Search Partners (GSP) Guided Search Partners is an Executive Search firm built on Trust, Transparency, Specialization, and Long-term Relationships. We connect high-performing professionals with organizations that value people, performance, and growth—helping leaders find roles where they can make an impact and build meaningful careers. About the Opportunity We’re supporting a search for a medical device manufacturing organization Quality Systems Manager with a in Fairfield, New Jersey. This role will serve as the primary owner of the Quality Management System and support compliance, audits, regulatory readiness, and continuous improvement. The organization is already compliant across required standards, but the goal is to strengthen the quality system, improve processes, and prepare for future growth. This is a strong opportunity for a hands‑on quality systems leader who wants ownership, visibility, and the chance to help move a compliant organization toward a stronger, best‑in‑class quality model. What You’ll Do You’ll lead and maintain the Quality Management System with a focus on compliance, audit readiness, regulatory expectations, and continuous improvement. Key areas of focus include: Serve as the primary owner of the Quality Management System Lead, maintain, and improve QMS compliance across the organization Support ISO 13485 and ISO 9001 quality system requirements Ensure alignment with applicable FDA and medical device regulatory expectations Support FDA site registration and 21 CFR Part 820 requirements Serve as a primary point of contact for regulatory bodies, notified bodies, and customer audits Manage core QMS processes including document control, CAPA, nonconformance management, supplier quality, internal audits, training systems, and risk management Lead cross‑functional teams to investigate quality issues and implement corrective actions Drive continuous improvement initiatives within the quality system Develop and deliver quality training across the organization Prepare and present quality metrics, audit findings, and compliance status to senior leadership Support future team growth, site launches, and quality system scaling efforts Who You Are You are a hands‑on, detail‑driven quality systems leader with strong medical device manufacturing experience. You understand how to own a QMS, manage audits, support regulatory expectations, and improve quality systems beyond basic compliance. You are comfortable being the main quality systems resource while helping build structure for future growth. You would do well here if you are organized, proactive, collaborative, and confident leading quality systems in a regulated manufacturing environment. Preferred Experience & Attributes Bachelor’s degree in Engineering, Quality, or related field 10+ years of experience in medical device manufacturing quality systems Direct ownership of QMS processes Experience implementing or maintaining ISO 13485 quality systems Strong working knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, and applicable regulatory guidance Hands‑on FDA site registration experience preferred Proven success leading internal and external audits Experience with CAPA, nonconformance management, supplier quality, document control, training systems, and risk management Experience driving continuous improvement within quality systemsStrong communication, documentation, and cross‑functional leadership skills Injection molding, assembly, machining, or precision manufacturing experience preferred Familiarity with electronic QMS platforms preferred ASQ certifications such as CQE, CQA, CMQ/OE, or equivalent preferred Why This Role Matters This role matters because the organization is preparing for continued growth and needs a quality systems leader who can strengthen compliance, improve processes, and support future expansion. The Quality Systems Manager will have the opportunity to own the QMS, influence quality culture, support regulatory readiness, and help build systems that can scale with the business. #J-18808-Ljbffr