SENIOR QUALITY ENGINEER
Our Client, One of the largest medical device companies based in Galway is currently recruiting Senior Quality Engineer . The successful candidate will lead and work as part of a team to maintain high quality and performance standards on all Medical products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.
• Lead and drive QA initiatives within area of functional responsibility.
• Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.
• Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.
• Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
• Strategically lead new product introduction and contract reviews from a QA perspective.
• Preparing and updating Operations procedures and associated documentation.
• Establishing inspection standards, plans, frequencies and test methods.
• Reporting functional are Quality metrics.
• Preparation of Quality reports for Operations meetings and management reviews.
• Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
• Performing and supporting internal and external audits to ISO and FDA requirements.
• Performing an active role in further development and continuous improvement of the quality management system.
• Supervision and direction of Quality personnel.
• Degree in Science / Engineering or related fields essential.
• Minimum of 5yrs industry experience in a medical device-manufacturing environment.
• Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
• Strong CAPA experience.
• Strong root cause analytical and problem solving skills.
• Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.
• New product introduction and manufacturing process transfer experience desirable.
• Demonstrated excellent organizational skills and ability to work on own initiative essential.
• Supervisory experience desirable.
• Excellent written and verbal communication skills essential
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255