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Purpose Statement
To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
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.
Support automated line and process with respect to all potential issues.
Be an agile team member who can support all functions are required based on shift requirements.
Complete investigation and analysis 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.
Perform internal quality audits.
Trending and analysis of key Quality metrics.
NFQ Level 6 or above in Science or Engineering Discipline.
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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