Design Quality Engineer
2 days ago
Design Quality Engineer II — Enniscorthy, Co. Wexford (Permanent, Full time)
Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role suits someone with a risk assessment and design quality mindset who can challenge design processes and ensure products meet the highest standards.
What You'll Do- Work closely with design, manufacturing, regulatory affairs, and compliance teams.
- Lead risk assessments on new devices, using FMEA tools to stress-test designs.
- Provide quality support across R&D, design, validation, and test methods.
- Review design documentation to ensure compliance with ISO 13485, ISO 14971, and CFRs.
- Perform statistical analysis and DOE to optimise products and processes.
- Support studies through different testing phases, ensuring design robustness.
- Contribute to biocompatibility assessments, protocol writing, and method validation.
- Engage in internal and supplier audits, driving continuous improvement.
- Degree in Engineering, Science, or Technical discipline.
- Minimum 5 years' experience in medical devices or pharmaceuticals.
- Strong knowledge of risk management and regulatory compliance.
- Experience with FMEA and other risk management tools (FMS experience an advantage).
- Skilled in statistics, validation, and test methods.
- Proven ability to challenge and stress-test designs to ensure product robustness.
- Strong communicator, able to work cross-functionally and independently.
- Flexitime with Monday–Thursday on site in Enniscorthy, and Friday morning from home.
- Join a dynamic, multidisciplinary team working at the interface of design, quality, and compliance.
- Exposure to cutting-edge development across multiple testing phases.
- A varied role where no two days are ever the same.
- Competitive salary and benefits package.
Interested? Contact [email protected]
Job Details- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Staffing and Recruiting
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