Social network you want to login/join with:
Reports To:
Associate Manager/Manager, Quality Assurance
Contract:
12 Month Contract
Shift:
Evening Shift. 3.00 pm - 11.00 pm (Some Flexibility)
Key Areas of Responsibility
To provide expert QA support to Operations, ensuring operational goals and objectives are achieved for the plant.
1. Be a Subject Matter Expert regarding Acceptable Quality Standards for products and processes.
2. Ensure regulatory compliance in area to cGMP standards of all medical device regulatory agencies (e.g., FDA and TUV).
3. Represent QA as the first point of contact for daily line support issues.
4. Troubleshoot product and process-related issues and identify root causes.
5. Work with QE’s and product teams to identify areas for risk reduction and error-proofing processes and assist in their implementation.
6. Drive awareness training with PTMs with the assistance of the manufacturing trainer.
7. Provide input into the disposition for any non-conforming product and identify appropriate corrective actions with support team members (MRB).
8. Perform internal quality audits.
9. Trend and analyze key Quality metrics.
10. Assist in the preparation of periodic reports.
11. Perform all other duties as assigned.
Qualifications, Knowledge, Skills
* Minimum of 2 years’ experience in a QA role.
* Knowledge of GMP-regulated environments; experience in a similar role is advantageous.
* Ability to manage obstacles and ambiguity; experience/training in problem-solving methodologies (e.g., Engineering Essentials TM).
* Builds strong relationships through open communication, respect, and trust. Diplomatic, tactful, with excellent interpersonal skills to help achieve outcomes.
* Strong analytical and problem-solving skills, process improvement orientation, and 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
#J-18808-Ljbffr