Senior Advanced Quality Engineer - Med Device NPD (Hybrid)

Stryker Corporation; Cork; Hybrid; Confidential; Full time

Job summary

Stryker Corporation in Cork, Ireland, is seeking a Senior Advanced Quality Engineer to lead quality activities across the product development lifecycle. You will guide NPD teams to ensure compliance with the quality system and external standards, including risk management and design/process verification and validation.

Responsibilities include leading risk management plans, developing inspection plans, and supporting manufacturing process development for new products.

Qualifications

• BS in a science, engineering or related discipline.
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belt preferred.
• Minimum of 3 years experience preferred.
• Experience in medical device product development lifecycle, including risk management and design/process verification and validation.

Responsibilities

• Lead quality engineering activities in the development of products to ensure the highest level of quality.
• Develop QA documentation to support new product development and regulatory submissions.
• Support design verification and validation tests and risk management activities.
• Lead design reviews and track mitigation of identified risks throughout development.
• Promote efficient testing practices and robust quality systems in manufacturing.
• Collaborate with Regulatory Affairs, Product Development and Manufacturing teams.

Skills

Risk management

CAPA

Root cause analysis

Project management

Cross-functional collaboration

Analytical thinking

Problem solving

Communication skills

Regulatory knowledge

Detail orientation

Education

BS in science/engineering

MS, CQE, or CRE preferred

Six Sigma Green Belt or Black Belt preferred

Tools

MiniTab

CAD drawings

Job description

Stryker Corporation in Cork, Ireland, is seeking a Senior Advanced Quality Engineer to lead quality activities across the product development lifecycle. You will guide NPD teams to ensure compliance with the quality system and external standards, including risk management and design/process verification and validation.

Responsibilities include leading risk management plans, developing inspection plans, and supporting manufacturing process development for new products.