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Oran McIvor
Life Science

+353 1 507 9270
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Senior Quality Engineer

Reference:AXPX-714514 Location: Westmeath
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Quality Engineer

Our client, a global leader in medical technology is seeking a Senior Design Quality Engineer to join their operations in Athlone. The candidate will be tasked to provide quality engineering support in the design and development of medical device products with reference to Airways, Breathing Circuits and Inhalation. Additionally, they will be required to facilitate in the application of design controls in product development, sustaining changes, and provide support in the rapid resolution of product complaints and/or safety issues.

• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
• Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.

• Engineering degree; BSc Mechanical Engineer
• 5 years experience in a similar role
• Display excellent verbal and writing communication skills – including protocol/report development and technical presentations
• Experience in Risk Management (ISO 14971)
• Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
• Working knowledge of and auditing experience to the FDA Quality System Regulations – ISO13485 and Medical Device Directive experience desirable.
• Experience in Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis – Desirable
• Familiar with statistical software tools such as Minitab, Stat Graphics and Statistical – Desirable
• Knowledge of Stability, Biocompatibility, Sterilization, Ship Testing Knowledge – Desirable
• Computer literate and experience with PCs, networks, and applications
• DFSS / Lean Green Belt or Black Belt - Desirable
• Familiar with DMAIC or DMADV(DFSS) methodologies - Desirable
• Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards - Desirable

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

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