Sr Design Quality Engineer

Skill Sets

General quality experience in medical devices preferred

Design Assurance / Design Quality

Self‑driven independent ability to engage with cross‑functional teams and manage project workload

Lean / Six Sigma project improvement experience

• Lead quality representation on global quality improvement, cost‑down, and efficiency projects.
• Engage in, review, and approve qualification deliverables, protocols, and processes.
• Ensure products and quality processes maintain regulatory compliance while achieving cost‑down and efficiency targets.
• Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess cost and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Deliver and/or manage projects; work with stakeholders to achieve desired results; mentor colleagues or direct the work of lower‑level professionals when required.
• Serve as a quality team member for Global quality (GOSC) efficiency projects across multiple products.

• 5–7 years of relevant experience, depending on education and experience.
• Advanced knowledge of quality management and related disciplines, typically obtained through a university degree and experience.
• Practical knowledge of project management.
• Experience with Lean/Six Sigma improvement methodologies.
• Experience in medical device or related industry preferred.
• Strong communication and influence skills, with ability to engage senior internal and external customers and vendors.
• Ability to work independently, coach and review work of lower‑level specialists, and manage projects and processes.
• Bachelor’s degree in engineering, quality, or related field and minimum 4 years of relevant experience; advanced degree with minimum 2 years of relevant experience acceptable.