Qc Executive

2 weeks ago

George Town, Penang, Malaysia Ambu Full time

Business Area:

Production- Employment type: Full-time
Responsibilities:

  • Lead & coordinate the QC inspectors to ensure all checking is performed to meet quality standard.
  • Review all production records for accuracy and completeness before approving for final product releasing.
  • Perform investigation of products defects with Production staff to eliminate the causes of quality issues and reduce the risk of failure.
  • Analyse quality problems to identify root causes and implement corrective action.
  • Reviewing quality records to ensure compliance and maintain files and documentation up to date.
  • Ensure that all operations are performed with compliance to GMP, ISO 13485, FDA and other related standards.
  • Establish training program for existing QC inspectors and new joined to ensure QC inspectors are properly trained.
  • Established an effective and efficient visual inspection method to reduce human factors variation during inspection.
  • Review and optimize QC inspection flow or plans.
  • Provide support to new project development or material change projects.

Requirements:

  • At least degree or above qualification with intermediate working experience under Quality or Manufacturing with a medical device company background.
  • Able to work independently.
  • Required language (written & spoken): English, Bahasa Malaysia.
  • Computer literate such as Microsoft Excel, Microsoft Word & PowerPoint.
  • Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820 are added advantage.

About Ambu:

Ambu has been bringing the solutions of the future to life since 1937.

Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions.

We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals.

Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

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