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Quality Assurance Manager

Job description

Key Responsibilities:

  • Ensure compliance with ISO 13485, GMP, product ISO standards, and all other applicable regulatory and quality requirements.

  • Manage and support internal, external, notified body, and customer audits.

  • Oversee the Quality Department to ensure it is adequately staffed, trained, and equipped, including the training of internal auditors.

  • Ensure all procedures and work instructions within the Quality Management System are properly maintained, updated, and aligned with regulatory requirements.

  • Plan and execute regular internal audits across all areas of the Quality System.

  • Assist in conducting supplier audits and participate in the evaluation and approval of new suppliers.

  • Monitor and ensure that all Non-Conformances (NCs) are reported, investigated, and resolved within reasonable timelines.

  • Oversee product inspection activities, ensuring proper inspection criteria are in place and applied.

  • Approve product release by issuing the Certificate of Conformance (CoC) / Certificate of Analysis (CoA).

  • Lead and manage validation activities related to new products, technology transfers, and process or design changes.

Key Requirements:

  • Bachelor's Degree (or higher) in Science, Engineering, or a related field.

  • Minimum of 3 years' managerial experience in Quality Assurance/Quality Control, ideally within the medical device industry.

  • At least 1 year of experience in a manufacturing environment certified to ISO 13485 is preferred.

  • Possess a Certified Quality Manager qualification or equivalent is an added advantage.

  • Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.

  • Experience working in a cleanroom environment.

  • Demonstrated ability to work both independently and in a team environment.

  • Strong interpersonal, analytical, and problem-solving skills.

  • Proactive, resourceful, and eager to learn.

  • Excellent written and spoken communication skills in English and Bahasa Melayu.

  • Computer literate with proficiency in standard office and quality-related software.

If this job isn't quite right for you, but you know someone who would be great at this role, why not take advantage of our referral scheme? We offer MYR500 in shopping vouchers for every referred candidate who we place in a role. Terms & Conditions Apply. https://www.ambition.com.my/refer-a-friend