Johnson & Johnson Careers
[Medical Devices] Senior Quality & Compliance Engineer
Requisition ID: 1805677554W
Overall purpose of job:
Major responsibilities are as following in accordance to STD, SOP, GMP, QSD related standards, and local Regulatory requirements.
1. Support to implement and maintain Quality System to ensure awareness and continual education across the local organization.
2. Support to conduct internal audit, audit to 3PL and suppliers if required.
3. Coordinate with local team and lead; drive the execution of corrective action and preventive action, ensuring the timely closure of CAPA actions, including 3PL partners.
4. Consolidate and track the quality compliance metrics, identify, analyze the gap with target, recommend initiatives for continuous improvement and compliance enforcement.
5. Support to the site management review.
6. Propose initiatives for quality performance improvement.
7. Drive for complaint vigilance execution in the country ensuring the timely closure of product related complaints cases.
8. Handle Adverse Event reporting to meet local regulation and J&J policy.
9. As a subject matter expert, train country in the QS system, auditing behaviors, complaint vigilance and process improvement methodologies, techniques, tools, language etc. to improve processes and improve business results.
10. Project assignment from the line manager.
|1. Prefer 3 years experience in managing quality functions in Medical Device or Pharmaceutical Industry|
2. Thorough knowledge & understanding of QSD/GMP regulations, !SO standards & local regulations
Johnson & Johnson Medical Taiwan Ltd. (8582)