Global Quality and Accreditation Specialist
2 days ago
At BSI, we're seeking a highly skilled professional to join our team as a Global Quality and Accreditation: Technical and Regulatory Reviewer. This role is a critical part of our organization, and we're looking for someone who can provide medical device quality management system ownership to our 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, investigate customer appeals, and review reports.
- Deliver certification decisions for ISO 13485 certifications and participate in smaller improvement projects to ensure 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.
- Perform competence verifier activities to support the auditor qualification process.
- 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 of quality management experience for medical devices.
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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Global Quality and Accreditation Specialist
3 weeks ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation SpecialistBSI is seeking a highly skilled Global Quality and Accreditation Specialist to join our team. As a key member of our quality management team, you will be responsible for providing technical expertise in key areas relating to certificate decision making, competence verification, and competence...
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Global Quality and Accreditation Specialist
2 weeks ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation SpecialistBSI is seeking a highly skilled Global Quality and Accreditation Specialist to join our team. As a key member of our quality management system, you will be responsible for providing technical expertise in key areas relating to certificate decision making, competence verification, and competence...
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Global Quality and Accreditation Specialist
4 days ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation SpecialistBSI is seeking a highly skilled Global Quality and Accreditation Specialist to join our team. As a key member of our quality management system, you will be responsible for providing technical expertise in key areas relating to certificate decision making, competence verification, and competence...
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Global Quality and Accreditation Specialist
3 weeks ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation: Technical and Regulatory ReviewerAt 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...
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Global Quality and Accreditation Specialist
4 weeks ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation: Technical and Regulatory ReviewerAt BSI, we're seeking a highly skilled and experienced professional to join our team as a Global Quality and Accreditation: Technical and Regulatory Reviewer. This role is a critical part of our organization, and we're looking for someone who can provide medical device quality...
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Global Quality and Accreditation Specialist
1 week ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation: Technical and Regulatory ReviewerAt 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...
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Global Quality and Accreditation Specialist
3 weeks ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation: Technical and Regulatory ReviewerAt 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 a critical part of our organization, and we are looking for someone who can provide medical device quality...
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Global Quality and Accreditation Specialist
5 days ago
Chaoyang Qu, China BSI Full timeJob Title: Global Quality and Accreditation: Technical and Regulatory ReviewerAt 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 a key part of our organization, and we are looking for someone who can provide medical device quality...
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Chaoyang Qu, China BSI Full timeGreat that you're thinking about a career with BSI! Role Title: Global Quality & Accreditation: Technical and Regulatory Reviewer Reporting: Global Quality & Accreditation: Technical Manager Location: UK/EU/APAC - Homebased The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally. ...
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Chaoyang Qu, China BSI Full timeAt BSI, we're seeking a highly skilled Technical Specialist to join our team in China or Japan. As a Microbiologist and Sterilization Engineer, you'll play a critical role in ensuring the quality and safety of medical devices.Key Responsibilities:• Conduct comprehensive audits of clients' management systems to ensure compliance with regulatory...
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Technical Specialist and Scheme Manager
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Chaoyang Qu, China BSI Full timeAre you a Microbiologist or Sterilization Engineer looking for a new challenge?BSI is seeking a highly skilled Technical Specialist and Scheme Manager (Microbiology) to join our team.Key Responsibilities:• Conduct comprehensive audits of clients' management systems to ensure compliance with regulatory and voluntary requirements.• Perform in-depth medical...
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Chaoyang Qu, China BSI Full timeAre you a Microbiologist or Sterilization Engineer looking for a new challenge?BSI is seeking a highly skilled Technical Specialist and Scheme Manager (Microbiology) to join our team.Key Responsibilities:• Conduct audits of clients' management systems to ensure compliance with regulatory and voluntary requirements.• Perform comprehensive medical device...
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Chaoyang Qu, China BSI Full timeAre you a Microbiologist or Sterilization Engineer looking for a new challenge?BSI is seeking a highly experienced Technical Specialist and Scheme Manager (Microbiology) to join our team.Key Responsibilities:• Conduct comprehensive audits of clients' management systems to ensure compliance with regulatory and voluntary requirements.• Perform in-depth...
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