Job Purpose:
To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
Key Responsibilities:
- Be the Subject Matter Experts with regard to Acceptable Quality Standards for products and processes.
- Ensure Regulatory compliance in area to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Represent QA as the first point of contact for daily line support issues.
- Troubleshoot product and process related issues and identifies root cause.
- Be an agile team member who can support all functions required based on shift requirements.
- Complete investigation of customer complaints.
- Work with QE’s and product teams to identify areas for risk reduction and error proofing processes and work on implementation of these.
- Drive Defect awareness training with product builders with the assistance of the manufacturing trainer.
- MRB: Provide disposition for any non-conforming product and identify appropriate corrective action with other support team members.
- Participate in internal quality audits.
- Trending and analysis of key Quality metrics.
Education & Experience:
- NFQ Level 6 or above in Science or Engineering Discipline.
- 2-5 Years experience in a similar position or medical device background.
- Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
- Learning ability, to learn an automated process and be comfortable to support on shift as required.
- Good interpersonal, planning & prioritising and communication skills are required for this role.
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