Job Description
I am collaborating with a global medical device company based in Dublin who are seeking a Senior Quality engineer to join their growing team.
This is an exciting time for the company as they continuously grow with new and existing projects in the pipeline. This person will be responsible for supporting the design control activities, using problem solving approaches and analytical skills to support NPD and product maintenance.
The Senior Quality Engineer will have minimum 5 years' experience in a similar role coming from the Medical Device and/or pharmaceutical industry with a degree in engineering or science. An excellent understanding and knowledge of industry and regulatory standards including ISO 13485, QSR, GMP essential with further knowledge of design control. Previous experience working in with quality systems, six sigma methodology, validation, and risk management desirable. You will have the ability to manage multiple projects and evaluate throughout.
Senior Quality Engineer Responsibilities:
1. Assist and conduct Failure Investigations and problem-solving sessions for non-conforming products Reviews.
2. Lead a team of quality technicians.
3. Quality Engineering approval authority for new and modified design/ process specifications including product performance specifications, test methods and process validation.
4. Consult with Manufacturing Plants
5. Lead risk management activities
6. Ensure design control elements are satisfied.
7. Ensure/perform process validation activities.
8. Support supplier qualification activities - risk classification assessment and product quality assessments
9. Evaluate test methods used in project activities.
10. Evaluation of customer requirements to identify applicable quality standards.
11. Release product (customer samples) during development activities
12. Realization of quality functional reviews
13. Ensure implementation of Pharmaceutical Systems global procedures and standards for QE engineering activities
14. Provide support to internal, regulatory body and customer audits and associated corrective actions.
15. Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
If this role is of interest to you, please 'apply now' or contact me today to discuss on 021 2300 300
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