Senior Advanced Quality Engineer – Medical Devices

Stryker Group; Cork; On-site; EUR 54,000 - 90,000; Full time

Job summary

Stryker Ireland is seeking a Lead Quality Engineer to drive quality activities in new product development and ensure compliance with design controls, risk management and medical device regulations.

You will prepare QA documentation, support verification and validation, lead risk assessments, facilitate design reviews, and collaborate with R&D, Regulatory Affairs and Manufacturing to deliver safe, effective products.

Qualifications

• BS in science, engineering or related discipline.
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belt preferred.
• Minimum of 3 years experience preferred.

Responsibilities

• Lead quality engineering activities in development of products.
• Develop QA documentation to support development and regulatory submissions.
• Support design control process improvements and risk management.
• Engage in design reviews and risk mitigation throughout development.
• Define verification/validation test requirements and provide evidence.
• Prepare final verification/validation reports with statistical support.
• Promote efficient testing practices and support manufacturing process development.
• Utilize statistical methods to determine acceptance limits and process parameters.
• Develop and approve inspection plans, routers, and drawings.
• Support product design transfers to manufacturing facilities.
• Evaluate predicate products for quality issues impacting development.
• Lead risk management activities and generate related plans/reports.

Skills

Project management

Cross-functional teamwork

Analytical thinking

Problem solving

Regulatory knowledge

Quality systems

Statistical analysis

CAD interpretation

Communication skills

Education

BS in science/engineering

MS, CQE, CRE preferred

Six Sigma Green/Black belt preferred

Tools

Mini-Tab

Job description

Stryker Ireland is seeking a Lead Quality Engineer to drive quality activities in new product development and ensure compliance with design controls, risk management and medical device regulations.

You will prepare QA documentation, support verification and validation, lead risk assessments, facilitate design reviews, and collaborate with R&D, Regulatory Affairs and Manufacturing to deliver safe, effective products.