Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Senior Quality Engineer to join their team.
Responsibilities include but are not limited to:
1. Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.
2. Complaint handling, NC management, Risk and Impact assessment, CAPA, Root cause investigation and solution development and verification and Change control.
3. Supplier Quality Management.
4. Product release.
5. Product test and release planning, change management and audit.
6. Critical thinking and technical writing.
7. Quality lead on multi/cross functional teams to achieve milestones and results.
8. Represents the company in Customer interactions relating to product process and system quality elements in a professional, constructive, and commercially aware manner.
9. Ensures that customer product requirements are defined and implemented within the site QMS.
10. Engage with the new product development team to ensure a smooth transition from development to production.
11. Identify and implement continuous improvements across the board and takes initiatives to make things better every day.
12. Owns and drives the Safety/Quality/Service/Cost Metric for the VS.
Job Requirements
1. Minimum of 5 years of direct QMS experience.
2. Validation experience, MSA experience and Gauge R&R experience.
3. On the job training will be provided for the right candidate.
4. Strong written and oral communication skills.
5. Experience working with medical device regulations is desirable.
6. Good computer skills in usage of MS Office Suite.
7. Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 and principles of GMP in the Medical Device Industry.
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