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[Medical Devices] Senior Q&C Engineer

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Job Description


Overall purpose of job:


Major responsibilities are as following in accordance to STD, SOP, GMP, QSD related standards, and local Regulatory requirements.

Essential duties and responsibilities:


  • Support to implement and maintain Quality System to ensure awareness and continual education across the local organization.
  • Support to conduct internal audit, audit to 3PL and suppliers if required.
  • 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.
  • Consolidate and track the quality compliance metrics, identify, analyze the gap with target, recommend initiatives for continuous improvement and compliance enforcement.
  • Support to the site management review.
  • Propose initiatives for quality performance improvement.
  • Drive for complaint vigilance execution in the country ensuring the timely closure of product related complaints cases
  • Handle Adverse Event reporting to meet local regulation and J&J policy.
  • 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.
  • Project assignment from the line manager.

Requirements:

  • Prefer 2 years experience in managing quality functions in Medical Device or Pharmaceutical Industry
  • Thorough knowledge & understanding of QSD/GMP regulations, !SO standards & local regulations
  • Strong leadership, influence, collaboration, and interpersonal skills. 
  • Knowledge of GSP, GWP, GDP, [SO and Quality Systems.
  • Analytical and process oriented with an interest/aptitude in operations.
  • Communication and presentation skills

Qualifications
see above
Primary Location
Taiwan-Taipei-Taipei-
Organization
Johnson & Johnson Medical Taiwan Ltd. (8582)
Job Function
Quality Assurance
Requisition ID
1905750731W