Manager, Quality Engineering

Who Our Client Is

Our client is a purpose-driven medical device organization dedicated to improving patient outcomes through innovation, quality, and integrity. They foster a collaborative environment where expertise is valued, ideas are welcomed, and teams work together to deliver meaningful impact.

What Our Client Needs

Our client is seeking a Quality Engineering Manager to lead design assurance and manufacturing quality for medical devices. This role serves as a subject matter expert, manages Quality Engineers, and partners with internal teams and external contract manufacturing organizations to ensure compliance and continuous improvement.

Who You Are

You are a strong quality leader with deep experience in medical device design and manufacturing. You bring a detail-oriented mindset and thrive in regulated environments. You communicate clearly, collaborate across functions, and mentor others to raise the standard of quality. You are confident leading investigations, managing risk, and guiding teams through complex compliance requirements.

What You'll Do

• Lead, manage, and mentor the Quality Engineering team

• Provide quality leadership for design control and development activities, including new products and design changes

• Serve as subject matter expert to Quality, R&D, and CMOs on design assurance and improvement techniques such as statistical sampling, Gage R&R, DOE, process capability, reliability analysis, and tolerance stack-up

• Author and oversee design control deliverables to ensure documentation is complete, traceable, and compliant with regulatory and internal standards

• Facilitate training for internal teams and CMOs on statistical techniques, problem solving, and Six Sigma methods

• Lead medical device risk management activities including risk management plans, hazard analysis, FMEAs, and benefit-risk analysis

• Lead root cause investigations in collaboration with CMOs and implement corrective actions to prevent recurrence

• Serve as Quality representative for change control, quality events, CAPAs, and audit records within the eQMS

• Support internal audits and regulatory inspections as subject matter expert

• This role includes supervisory responsibility for the Quality Engineering team.

What You'll Need

• Bachelor's degree in Science, Engineering, or equivalent combination of education and experience

• 10+ years of experience in quality, engineering, or a related role within a cGMP, medical device, or regulated industry

• Strong experience in design control, validation, manufacturing quality, data analysis, statistical techniques, investigations, root cause analysis, CAPA, and nonconformance management

• Experience managing or mentoring personnel preferred

• Proficiency with Word, Excel, PowerPoint, and Minitab

• Master's degree in a related discipline preferred

• Certified Six Sigma Black Belt or ASQ Certified Quality Engineer preferred

What They Offer

• Opportunities for professional development and career growth

• Collaborative and innovative work environment

• Medical, Dental, and Vision Insurance

• Life and AD&D Insurance

• Short- and Long-Term Disability Coverage

• 401(k) with generous company match

• Health Savings Account (HSA) and Flexible Spending Account (FSA) with company match

• Wellness Program and Employee Assistance Program (EAP)

• Generous Paid Time Off (PTO)

Equal Opportunity Statement

Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual-regardless of background-feels valued, respected, and empowered to thrive. Discrimination or harassment of any kind is strictly prohibited.

Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.