Ref. no.: JO-1106-232591
Job description: Senior Quality Engineer
In partnership with its client, Kenny-Whelan is currently seeking a Senior Quality Engineer to work for their client in the Galway area. Provide quality engineering support in design and development of medical device products, and facilitate the application of design controls.
Job Responsibilities:
• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation.
• Ensure successful transfer of new products to production facility. Review production processes for quality of validation.
• Review and approve verification and validation test plans. Ensure verification results demonstrate compliance to medical device standards.
• Provide training to project teams on verification/validation statistical methods and design controls.
• Lead product risk assessment efforts within product teams.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
• Conduct internal quality system and supplier quality audits.
Skills, Abilities and Education:
• B.Sc. Or M.Sc. in an engineering discipline
• 5+ years of quality engineering experience
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Experience with test methods and standards for the design, verification, and validation of medical device products.
• Skilled in test plan development and root cause failure analysis.
• Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments.
• Good verbal (including presentation) and written communication skills, especially technical report writing.
• Ability to effectively work on project teams.
• Familiar with reliability analysis and test methods.
• Familiar with ISO 14971. Experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP.
• Manufacturing engineering or manufacturing quality engineering experience preferred.
• ASQ CQE or CRE certification.
Desirable:
• Spanish proficiency desirable
• Will be working in cross-functional teams as the Quality System expert.
• Normal office conditions.
• Up to 10% travel required.
Kenny-Whelan Contact:
If you are interested in the above role, please send an updated CV marked for the attention of Linda Nugent, email: lnugent@kenny-whelan.ie or telephone for a confidential chat on 021-4665407