Quality Engineering Manager

Compensation: $120,000 – $140,000 annually

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Bonus: Eligible for annual discretionary bonus. Bonus eligibility and amount are based upon company and/or individual performance.

LHH is partnering with a global medical device manufacturing organization seeking a Quality Engineering Manager to serve as the site Quality Leader and Management Representative within an FDA and ISO 13485 regulated environment.

This role is a key member of the Plant Leadership Team and oversees a team of 20+ associates, including 7 direct reports, across multiple buildings. The position requires strong regulatory knowledge, leadership capability, and customer engagement experience.

• Lead and maintain the site Quality Management System (QMS) in compliance with FDA and ISO 13485 standards
• Provide strategic oversight of quality assurance and regulatory programs
• Oversee document control, CAPA, complaint handling, discrepancy management, product release, and environmental monitoring systems
• Manage internal and external audits and drive corrective actions
• Partner with plant leadership and corporate quality to achieve KPIs
• Lead quality engineering and inspection teams to improve efficiency and resolve root cause issues
• Serve as primary quality contact for customers and suppliers
• Develop, coach, and evaluate quality personnel
• Ensure ongoing regulatory and customer compliance

• Bachelor’s degree in Engineering, Quality, or related field
• 5+ years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or another regulated industry (automotive or aerospace)
• Experience in precision machining and/or metal processing required
• Strong knowledge of ISO 13485, FDA regulations, and CAPA processes
• Experience managing internal and external audits and maintaining robust QMS systems
• Experience with CMM programming and inspection systems
• Ability to interpret blueprints and technical drawings
• Proficiency in Microsoft 365
• Experience with ERP and quality management systems
• Experience with statistical analysis tools such as Minitab preferred

• Occasional lifting up to 20 lbs.
• Visual acuity for inspection activities
• Minimal overnight travel (up to 10%)

• Medical, dental, and vision insurance (effective date of hire)
• Company-paid life insurance
• Company-paid short-term and long-term disability insurance
• 401(k) retirement plan with company match
• Paid Time Off (PTO) and 10 paid holidays annually
• Voluntary life insurance options
• Voluntary long-term care insurance
• Voluntary legal plan

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers