Quality Engineering Manager

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Quality Engineering Manager – Medical Device Manufacturing to join their team. This is a high-impact leadership role for a quality professional who thrives in technically complex settings and enjoys leading, mentoring, and elevating teams.

This position sits on the site leadership team and serves as the senior quality authority for the facility, overseeing quality systems, regulatory compliance, and continuous improvement initiatives across the organization.

• Leadership responsibility for an established quality organization (15+ quality professionals).
• Strong blend of hands‑on technical depth and strategic leadership.
• Highly visible role with direct influence on operational excellence and customer satisfaction.
• Stable organization with long‑term growth and investment in quality.

• Provide strategic and operational leadership for site‑wide quality engineering and compliance activities in a regulated manufacturing environment.
• Own and continuously improve the Quality Management System (QMS), ensuring alignment with FDA, ISO 13485, AS/ISO, and customer requirements.
• Lead and develop a multi‑layered quality team, including quality engineers, inspectors, and technical specialists.
• Serve as the management representative for quality, acting as the primary point of contact for audits, regulatory interactions, and customer quality matters.
• Drive root cause analysis, CAPA, nonconformance resolution, and risk mitigation using data‑driven methodologies.
• Partner cross‑functionally with Operations, Engineering, Supply Chain, and Leadership to support product launches, validations, and process improvements.
• Oversee internal and external audits, customer visits, and supplier quality engagements.
• Ensure robust document control, training systems, product release processes, and inspection strategies.
• Leverage metrics and KPIs to identify trends, improve performance, and support business objectives.

• Bachelor’s Degree in Engineering, Quality, or a related technical discipline.
• Proven people leader with experience managing large teams (15+ direct and indirect reports).
• Background in Medical Device or other highly regulated manufacturing industries.
• 5+ years of progressive quality engineering leadership experience.
• Strong technical foundation in precision machining, metal manufacturing, or tight‑tolerance production environments.
• Hands‑on experience with: CMM programming and advanced inspection systems, blueprint reading and GD&T interpretation, and statistical analysis and quality tools (SPC, root cause methodologies).
• Deep working knowledge of regulatory and quality standards (FDA and ISO 13485).
• Experience leading audits and maintaining compliance in complex manufacturing settings.
• Experience working within multi‑building or multi‑operation sites.
• Familiarity with enterprise quality systems, ERP platforms, and data visualization tools.
• Demonstrated ability to coach, mentor, and build high‑performing technical teams.

$120,000 - $140,000

2 weeks of vacation, paid sick leave where applicable by state law, Medical Insurance, Dental Insurance Vision Insurance, 401K, and Life Insurance.

If you are a passionate Quality Engineering Manager looking for anew and rewarding career, please apply today! You don’t want to miss out on this opportunity!

Equal Opportunity Employer/Veterans/Disabled

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