SHL MEDICAL

Senior Quality and Regulatory Expert – Medical Devices

Full time         Taoyuan, Taiwan          Updated: January, 2018

Description

In order to maintain the highest quality standards in our innovative products, our business unit Engineering Solutions in Taiwan is currently looking for a dedicated QA/RA expert with extensive experience in the medical device industry, who is looking for a new challenge in delivering high quality, innovative solutions to pharma and healthcare.

Your responsibilities

  • You will lead all QA/RA related activities of the department, including regulatory strategy development
  • You will be the main contact point for quality and regulatory related topics in our device projects
  • You will have a leading role in developing, establishing and maintaining internal quality standards and guidelines
  • You will be responsible for regulatory compliance of 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 strongly interact with other departments in the organization, suppliers and customers on quality and compliance topics
  • You will lead internal and external audits

Your qualifications

  • BA/MA or Ph.D. degree in Engineering or Applied Sciences
  • Degree program and/or work experience overseas (Europe, Australia, Americas) is an asset
  • 6+ years of relevant industry experience in regulatory and quality of medical devices
  • Substantial experience with design control and development as well as verification and validation of medical devices
  • Experience with regulatory compliance and filing for electro-mechanic, electronics and/or software-based medical device products is a major asset
  • Knowledge of relevant regulatory requirements and standards for medical devices (ISO13485, 21 CFR 820, ISO14971, CE, IEC60601, IEC62366, IEC62304, MDR, etc.)
  • Background in product development is an asset
  • Certified auditor training is an asset
  • Excellent written and oral communication and negotiation 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 own ideas to the success of SHL

For further information on this position or SHL Group, please contact: Margo.Hao@shl-group.com, HR Department.