Job Description
To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant. 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. Represent QA as first point of contact for daily line support issues. Troubleshoot product and process related issues and identify root cause. Work with QE's and product teams to identify areas for risk reduction and error proofing processes. Drive awareness training with PTMs.
Key Responsibilities:
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.
Assist in the preparation of periodic reports.
Qualifications:
Level 6 qualification in related quality discipline.
Minimum of 2 years' experience in a QA role.
Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
Strong analytical and problem-solving skills, process improvement orientation, and ability to handle multiple tasks in a fast-paced, results-oriented environment.
Strong customer engagement and credibility by delivering on expectations and commitments.