Senior Quality Engineer, Medical Devices Risk & Validation

Stryker Corporation; Carrigtohill; On-site; Confidential; Full time

Job summary

Stryker Corporation seeks a Lead Quality Engineer to drive quality activities across the New Product Development lifecycle. You will develop QA documentation, maintain the design control system, and participate in design reviews to identify risks and mitigation strategies.

The role requires extensive collaboration with cross‑functional teams to ensure regulatory readiness and product integrity. The ideal candidate has a science/engineering background with 3+ years in medical devices, strong

Qualifications

• BS in science, engineering, or related discipline is required.
• Master’s, CQE, or CRE preferred to support advanced QA activities.
• Minimum 3 years of relevant experience in medical device quality.

Responsibilities

• Develop quality assurance documentation to support new product development and regulatory submissions.
• Support quality system maintenance for design control by correcting deficiencies in procedures.
• Engage in design, development, manufacturing, and risk management activities.
• Participate in design reviews to identify risks and track mitigation across development.
• Define design verification and validation test requirements with objective evidence.
• Complete final V&V reports with concise conclusions and statistical support.
• Promote efficient testing practices and support manufacturing process development.
• Utilize standard statistical methods to set acceptance limits and resolve quality problems.
• Develop, review, and approve inspection plans, routers, and drawings for new products.
• Support product design transfers to internal/external manufacturing facilities.
• Evaluate predicate products for quality issues impacting new developments.
• Analyze and define critical quality attributes through risk analysis.
• Collect market feedback on new products and address early concerns.
• Lead risk management plans, reviews, and verify effectiveness of controls.

Skills

Quality system adherence

Risk management

Design for quality

Statistical analysis

Regulatory knowledge

Communication skills

Education

Bachelor of Science in science/engineering

Master’s, CQE, or CRE preferred

Tools

MiniTab

Job description

Stryker Corporation seeks a Lead Quality Engineer to drive quality activities across the New Product Development lifecycle. You will develop QA documentation, maintain the design control system, and participate in design reviews to identify risks and mitigation strategies.

The role requires extensive collaboration with cross‑functional teams to ensure regulatory readiness and product integrity. The ideal candidate has a science/engineering background with 3+ years in medical devices, strong