Global Quality and Accreditation Specialist

1 week ago

Chaoyang Qu, China BSI Full time
Job Title: Global Quality and Accreditation: Technical and Regulatory Reviewer

At BSI, we are seeking a highly skilled and experienced professional to join our team as a Global Quality and Accreditation: Technical and Regulatory Reviewer. This role is responsible for providing medical device quality management system ownership to medical device and QMS audit teams globally.

Key Responsibilities:
  • Develop and maintain technical expertise in key areas relating to certificate decision making, competence verification, and competence monitoring.
  • Support ad hoc improvement projects and provide technical support for the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes.
  • Support the roll out of policy decisions and processes for medical device QMS audits globally, and provide support for the ISO 13485 certification and CE schemes.
  • Deliver certification decisions for ISO 13485 certifications and participate in smaller improvement projects ensuring appropriate adherence to procedures.
  • Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing, and other BSI colleagues on BSI QMS requirements for medical devices.
  • Competence verifier activities to support the auditor qualification process, if appropriate.
Requirements:
  • A good understanding of QMS requirements as applied to medical devices, including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR, and MDSAP requirements).
  • A good understanding of product and QMS certification concepts and principles.
  • A comprehensive understanding of quality systems, philosophies, and principles.
  • An awareness of certification, accreditation, and notified body roles.
  • Experience of coordinating or conducting audits of medical device manufacturers to ISO13485 (e.g., supplier or internal audits).
  • Minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.
Our Excellence Behaviours:

Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

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