Validation Lead

Role Summary:

An exceptional opportunity has arisen for a Validation Lead in the thriving medical device industry, located in scenic Co. Mayo, where you will get a perfect blend of professional opportunity and quality of life, surrounded by stunning natural beauty and a vibrant community.

This pivotal role involves leading the Quality Engineering (QE) Validation team while supporting a wide range of Quality Assurance activities across the site.

The successful candidate will collaborate closely with key departments, including Engineering, Manufacturing, Supply Chain, Product Development, and Corporate Quality Management and R&D.

Key Responsibilities:

• QE Project Support: Provide expert QE support for New Product Development (NPD), change control, feasibility studies, and other key projects.
• Team Leadership: Lead the Validation Quality Engineering team, mentoring and guiding QEs to ensure timely project completion.
• Resource Planning: Strategically plan resources and timelines for validation lifecycle activities in collaboration with the Engineering team.
• Quality Improvement: Drive quality improvements in partnership with the Quality Manager to maintain and enhance quality standards.
• Internal Audits: Conduct internal audits as per the audit schedule, ensuring compliance with all relevant regulations and standards.
• CAPA Support: Support the Corrective and Preventive Action (CAPA) system, contributing to ongoing quality assurance.

Experience and Qualifications:

• Experience: 5-8 years of relevant experience in the medical device industry or an equivalent regulated sector. People management experience is highly desirable.
• Education: A Degree in an Engineering or Science discipline, along with a Quality Engineering qualification or equivalent.
• Certified Quality Engineer (CQE) qualification or its equivalent is preferred.

 

For further information on this role please contact Regina at 086 0100 903 or at jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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