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Sr QMS Manager (Medical Device)

Sr QMS Manager (Medical Device)

Michael PageMalaysia, Malaysia
11 jam yang lalu
Penerangan pekerjaan

Overview

  • Chance to be part of company expansion
  • Great remuneration package

About Our Client

The hiring company is a large organization within the life science industry, specializing in the production of medical devices. Known for its emphasis on quality and innovation, the company offers a stable and structured environment to foster professional growth.

Job Description

  • Lead and manage the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards.
  • Oversee internal and external audits, addressing any non-conformities effectively.
  • Develop and implement quality policies, procedures, and performance metrics.
  • Collaborate with cross-functional teams to support product development and continuous improvement initiatives.
  • Ensure regulatory compliance for medical devices in domestic and international markets.
  • Manage documentation control and risk management processes.
  • Provide training and mentorship to the quality assurance team.
  • Act as the main point of contact for regulatory bodies and certification organizations.
  • The Successful Applicant

    A successful Sr QMS Manager should have :

  • A degree in engineering, life sciences, or a related field.
  • Hands-on experience managing Quality Management Systems (QMS) within the medical device industry.
  • Knowledge of ISO 13485, FDA regulations, and other relevant standards.
  • Strong leadership skills with the ability to manage and motivate teams.
  • Excellent problem-solving and communication abilities.
  • What’s on Offer

  • 13th-month salary and manager allowance included.
  • Supportive and structured work environment focused on professional development.
  • Exposure to cutting-edge processes and technologies in the medical device sector.
  • If you are passionate about quality management in the life science industry and are looking for a fulfilling role, we encourage you to apply today!

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