Here in Hays Recruitment, our Medical Devices Client in Dublin is hiring a Product Quality Engineer. They should have a keen aptitude for implementing and maintaining standards and driving efficiency within the business.

The right candidate will be an experienced Product Quality Assurance Engineer in an ISO 13485 and FDA 21 CFR IVD manufacturing environment, with experience in product and process quality for medical devices, including new product introductions.

Responsibilities

• Proven experience in QMS working in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation. It has demonstrated strong competencies and leadership in these areas.
• Prominent in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, CAPA, continuous improvement changes, and post-production (proactive surveillance). This will require a system's mindset incorporating a cross-technology understanding, in addition to a core appreciation of risk and regulatory requirements.
• Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.

Education and/or Experience:

• Minimum of Bachelor’s degree in relevant technical discipline (ideally Engineering, Quality or Science)
• Minimum 5 years’ relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management, incl. writing and / or reviewing quality related procedures, plans and reports.
• A high-paced individual who is eager and passionate about developing and delivering quality solutions in close collaboration with key stakeholders.
• Leadership skills in quality and an ability to influence cross-functional teams to drive work scope to completion.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.