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Contact Info
Oran McIvor
Life Science

+353 1 507 9270
oran.mcivor@lifescience.ie
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Details

Senior Quality Engineer


Reference:AKVG-686557 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer

Our client, a global healthcare manufacturerwithin the medical device sector is searching for a Senior Quality Engineer to provide quality engineering support in the 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.

Roles/Responsibilities:
• Review new 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 FDA Quality Systems Regulations Design phases.
• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, conflicting and feasible product requirements that support the market needs.
• Participate within cross-functional teams to develop product risk management file (risk management plan, 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
• 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.

Skills/Experience:
• BS Degree required
• 5-8 years industry experience required (MS degree 3-5 years experience; PhD 0-3 years experience)
• Strong familiarity with regulatory requirements (ISO 13485,CFR 820 & EN ISO 14971)
• Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 – Considered an 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.
• Experience with ASQ CQE, CRE, CSQE certification desirable, but not essential.
• Good verbal and written communication skills including protocol/report development and technical presentations.
• Experience with Risk Management, FTA, FEMEA, HACCP.
• Experience with Comparative Statistical techniques, sampling plans, GR&R,k K-factor, hypothesis testing and ANOVA.
• Experience in test plan development and root cause failure analysis.
• Experience in working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistic), Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.
• Familiar with ICE 60601 and production specific standards.
• Familiar with DMAIC or DMADV(DFSS) methodologies.
• Experience with DFSS/Lean Green Belt or Black Belt
• Computer literate and experience with PCs, networks and applications.



If you would like further Information you can contact the recruiter directly:



Oran McIvor | Tel: +353 (0) 1 507 9270