Be a Subject Matter Expert 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.
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 input into the 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.
Responsible for the timely analysis of customer complaints to acceptable Quality Standards supporting Divisional and Operational goals and objectives.
Complete investigation and analysis of customer complaints.
Maintain systems for the receipt and recording of customer complaints.
Assist in the preparation of periodic reports.
Maintain biohazard laboratory.
Maintain systems for Customer complaints.
All other duties as assigned.
What you will need:
2 years’ experience min in relevant position in industry.
Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
Good knowledge of statistics would also be an advantage.
Can manage around obstacles and ambiguity. Experience/training in problem solving methodology. (Engineering Essentials TM)
Builds strong relationships by fostering open communications, respect, and trust. Is diplomatic, tactful and leverages excellent people skills to help achieve outcomes.
Analytical & critical thinking skills, process improvement orientation, and the ability to manage multiple tasks in a fast-paced, results-oriented environment.
Builds strong customer engagement and credibility by delivering on expectations and commitments.