Description
I have an immediate opening for Senior Quality Engineer (Metrology & Calibration Department) with a leading medical device company based in Waterford. This is a permanent position with a competitive salary on offer.Objectives:
- To provide support to the Quality Systems Development Manager in maintenance, review and improvement of the Quality System.
- Site SME for metrology
- To supervise the calibration team.
- To oversee the quality aspects of metrology, calibration and sterilisation functions.
- Identifying trends and to tighten up controls / appraisals where appropriate
- Liaise with external agencies on type testing.
- To provide expert knowledge in Contact lens ISO standards
- Lead the Cost of Quality Reduction activity for calibration.
- To liaise with external auditors and regulatory bodies
Responsibilities:
- Perform day to day supervisory activities for the calibration team, including budget oversight.
- Assist with identifying emerging Metrology technologies, gather requirements, evaluate the technologies, and make recommendations for new technologies which will provide potential competitive advantage in the area of measurement.
- Provide knowledge on the set up and operation of all metrology equipment and assist in technical guidance and fault diagnosis.
- To identify best practice procedures for metrology equipment set up and maintenance.
- Write metrology requirements/specification in order to procure and support validation activities in line with business needs.
- Procedure and test method development.
- Carry out data analysis and investigate metrology issues and perform follow up corrective and preventative actions.
- Identify opportunities for Cost of Quality reduction (COQ) and lead COQ initiatives for calibration.
- Ensure all metrology equipment is fully capable, fully documented and that operations are trained to maintain it.
- Additional requirements of the job will be specified by the Quality Systems Development Manager
Qualifications:
- Third level Qualification in Science or Engineering, specific metrology qualification an advantage.
- 3 years plus experience in a supervisory position.
- Statistics/Six Sigma qualification desirable
- Minimum 5 years' experience in a regulated pharmaceutical/medical device environment
- Project management experience desirable
- Supervisory experience desirable
- Validation experience
- Good communication skills
- The ability to motivate and influence people
- Self-starter, highly motivated with the ability to prioritize
If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for further information