Senior Quality Expert – Medical Devices

Full time         Taoyuan, Taiwan          Posted 1 month ago


We’re seeking for our Engineering Solutions unit in Taiwan a dedicated quality expert with extensive experience in the medical device industry who is looking for a new challenge to deliver high quality, innovative solutions to the pharmaceutical and healthcare industry.

Your Responsibilities

  • You will be the main contact point for all quality related topics in our device projects
  • You will play a leading role in developing, establishing and maintaining internal quality standards and guidelines
  • You will be responsible for overlooking regulatory compliance in risk management, validation and conformity evaluation activities within the organization
  • You will drive the continuous improvement process within the quality and compliance team
  • You will interact regularly with other departments in the organization, as well as with suppliers and customers on quality and compliance topics
  • You will lead internal and external audits

Your Qualifications

  • BA/MA degree in Engineering or Applied Sciences
  • Degree program and/or work experience overseas (Europe, Australia, Americas) is an asset
  • 5+ years of relevant industry experience in quality assurance of medical devices (preferably combination products)
  • Experience with verification and validation, design control and development of medical devices
  • Knowledge of relevant regulatory requirements and standards (ISO13485, 21 CFR 820, ISO14971, GMP, FDA CFR21)
  • Experience with regulatory compliance for electronics and software products is a major asset
  • Excellent written and oral communication skills (English)
  • Diligent, reliable and target oriented working attitude
  • Ability to pursue and drive projects independently

What We Offer

  • Competitive compensation package
  • Modern working environment with state-of-the-art facilities and technologies
  • Challenging tasks in a fast growing and innovative industry
  • Position in a young, dynamic and international team of highly skilled professionals
  • Opportunity to work independently and contribute personal ideas to the success of SHL

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