[Medical Devices] Senior Q&C Engineer

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