Senior Quality Engineer - Medical Devices, Hybrid/Remote

Stryker Corporation; Carrigtwohill; Hybrid; EUR 47,000 - 77,000; Full time

Job summary

Stryker Ireland is seeking a Senior (Advanced) Quality Engineer to influence design verification, risk management, and manufacturing processes for new product development. The role ensures compliance with FDA QSR, ISO 13485 and the Stryker quality system while driving reliability, human factors engineering, and measurement of product quality across development teams.

Hybrid or onsite work with full benefits.

Qualifications

• Bachelor in science or engineering (Level 8).
• 2+ years in technical or quality engineering in R&D or manufacturing.
• Experience with medical device lifecycle, risk management, and V&V.

Responsibilities

• Define design requirements and develop manufacturing processes for new product development.
• Drive reliability engineering, risk management and design validation.
• Develop QA documentation to support new product development and regulatory submissions.
• Guide product development teams through internal quality system requirements.
• Lead risk analyses and mitigation strategies for new products.
• Engage in design reviews and verify/validate testing to ensure acceptance criteria.

Skills

Quality engineering

Risk management

Design validation

Statistical methods

Education

Bachelors in science/engineering (Level 8)

Tools

FDA QSR compliance

ISO 13485

Job description

Stryker Ireland is seeking a Senior (Advanced) Quality Engineer to influence design verification, risk management, and manufacturing processes for new product development. The role ensures compliance with FDA QSR, ISO 13485 and the Stryker quality system while driving reliability, human factors engineering, and measurement of product quality across development teams.

Hybrid or onsite work with full benefits.