Senior Quality Engineer - Operations

Job description

The Senior Operations Quality Engineer is a member of the Operations Quality group, who will report to the Operations Quality Manager. S/he is responsible for Operations Quality within their prescribed area of functional responsibility. The successful candidate will lead and work as part of a team to maintain high quality / performance standards. 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.


Major Accountabilities:

  • 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
  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness
  • 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
  • Develop strong links with customer organizations and other project stakeholders
  • Understanding of standard metrology good practice
  • Quality review of functional area validation documentation
  • 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
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS etc.
  • Supervision and direction of Quality personnel
  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives



  • 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


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent