Compliance Specialist

19 hours ago


Petaling Jaya, Selangor, Malaysia Hartalega Holdings Berhad Full time

Hartalega Holdings Berhad, a leading manufacturer of nitrile gloves, is seeking a highly skilled Compliance Specialist to join our team.

Responsibilities
  • Assist the Manager in establishing, monitoring, maintaining, and continuously improving our Quality Management System (QMS).
  • Conduct internal quality audits as per the Internal Quality Audit Procedure and Plan, covering all elements in the EN ISO 13485:2016, MDSAP, ISO 9001:2015, Medical Device Directives (MDD 93/42/EEC), and Medical Device Regulations (MDR 2017/745) standards.
  • Support the Manager in facilitating and attending customer/external/third-party certification body audits.
  • Issue Corrective Action (CAR) or Preventive Action (PAR) for nonconformities identified during audits.

This role requires a Bachelor's Degree in Science or Engineering field, minimum 3 years of working experience in auditing and medical devices manufacturing environment, strong hands-on knowledge in ISO 13485:2016 and ISO 9001:2015 standard requirements, good communication skills in both verbal and writing, including listening skills (both English and Bahasa Malaysia), sound knowledge in data analysis, and auditing skills, and ability to work in tight deadlines, plan, organize, and detail-oriented.



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