Work Flexibility: Onsite

Position Summary

To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.

Key Areas of Responsibility

• 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.

Qualification Knowledge Skills

• Minimum qualification: NCEA diploma in related discipline.
• Previous experience in industry desirable.
• 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 interpersonal skills to help achieve outcomes.
• Analytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
• Builds strong customer engagement and credibility by delivering on expectations and commitments.

Travel Percentage: None