Senior Design Quality Engineer
Our client, a medical device company are currently looking to recruit a Senior Quality Engineer for their Athlone site.
Summary of Position:
Provide quality engineering support in design and development of medical device products, specifically ventilators. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.
- Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 & EN ISO 14971)
- Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
- Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.
- Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis.
- Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis.
- ASQ CQE, CRE, CSQE certification desirable, but not essential.
- Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
- Ensure design changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.
- Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs.
- Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
- Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
- Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab.
- Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
- Review Design History Files and Technical Files for conformance to applicable requirements.
- Assist, when appropriate with internal and supplier audits.
- Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
- Support the Regulatory Department in writing technical submissions.
- LEVEL 8 BS with 5 years' experience.
- Strong familiarity with regulatory requirements ISO 13485, CFR 820 & EN ISO 14971.
- Good verbal and written communication skills including protocol / report development and technical presentations.
- Risk Management, ISO 14971, FTA, FMEA, HACCP.
- Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA.
- Test plan development and root cause failure analysis.
For further information on this Senior Quality Engineer role in Galway please contact Cliona O'Malley on 091730022 / email@example.com
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