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Senior Quality Assurance Manager

2 weeks ago


Kuala Lumpur, Kuala Lumpur, Malaysia AMREP SUPPLIER MANAGEMENT SERVICES Full time

An experienced ISO 13485 Quality Auditor with substantial experience in quality management systems (QMS) and factory auditing is required to conduct technical, QMS, and compliance audits on medical devices. This role involves performing on-site audits of production facilities, reviewing quality management protocols, evaluating production processes for compliance with quality requirements, and completing audit reports.

Responsibilities:

  • Conduct on-site ISO 13485 QMS audits of production facilities
  • Review and implement quality management protocols
  • Evaluate production processes for compliance with quality standards
  • Prepare and deliver comprehensive audit reports

Requirements:

  • Proven quality audit experience
  • Experience working in manufacturing environments
  • In-depth knowledge of medical device production, ISO 13485, and quality management practices
  • Strong communication and interpersonal skills

About AMREP Supplier Management Services:

AMREP Supplier Management Services is a global third-party supplier quality management company dedicated to helping clients achieve their production and quality objectives.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance