Who Our Client Is

Our client is a medical device organization committed to quality, compliance, and continuous improvement. They foster a collaborative environment where teams work closely across functions and with external partners to deliver safe, effective products.

What Our Client Needs

A Senior Quality Engineer to serve as a key quality representative for medical device products, design activities, and manufacturing processes, with a strong focus on supplier quality and compliance.

Who You Are

You are detail-oriented, analytical, and comfortable working across functions and with external partners. You communicate clearly, manage multiple priorities, and bring a strong quality mindset to regulated environments.

What You’ll Do

• Provide quality support for design control and development activities for new products and design changes
• Collaborate with Quality, R&D, and CMOs to apply Six Sigma and statistical techniques during development and design changes
• Author and support design control deliverables to ensure development requirements are documented and compliant
• Lead risk management activities for new and existing product design changes
• Contribute to verification and validation planning and reporting
• Lead root cause investigations with CMOs and drive effective corrective actions
• Serve as quality representative for change control, quality events, CAPAs, and audit records in the eQMS
• Perform supplier quality activities including supplier qualification, ASL maintenance, audit scheduling, and supplier audits
• Coordinate and facilitate Quality System Management Reviews
• Act as subject matter expert during internal audits and regulatory inspections

Travel up to 25% as needed for CMO engagement, design support, and audit or inspection activities. No supervisory responsibilities.

What You’ll Need

• Bachelor’s degree in Science, Engineering, or an equivalent combination of education and experience
• 5 or more years of experience in a quality, engineering, or regulated industry role, preferably in medical devices
• Experience with manufacturing and design quality, validation, and design control
• Hands-on experience with investigations, root cause analysis, CAPA, and nonconformance management
• Working knowledge of data analysis and statistical techniques
• Experience using Lean Six Sigma tools
• Strong communication, presentation, time management, and cross-functional collaboration skills
• Proficiency with standard computer tools including Word, Excel, PowerPoint, and statistical software
• Six Sigma certification or ASQ Certified Quality Engineer preferred

What They Offer

• Private health and dental coverage for employees and eligible dependents
• Employer pension contribution of 7.5%
• Income protection and life assurance
• Employee Assistance Program (EAP)
• Eligibility for the company ownership program
• 25 days of annual leave, increasing by one day after five years of service, up to a maximum of 28 days
• Full-time schedule of 39 hours per week
• Free on-site parking

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.