Global Quality and Accreditation Specialist
3 weeks 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 key 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, 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.
- 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.
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
4 weeks ago
Spalding, Lincolnshire, United Kingdom 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 weeks ago
Spalding, Lincolnshire, United Kingdom 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
1 month ago
Spalding, Lincolnshire, United Kingdom 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
1 month ago
Spalding, Lincolnshire, United Kingdom 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
Spalding, Lincolnshire, United Kingdom 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...
-
Global Quality and Accreditation Specialist
3 weeks ago
Spalding, Lincolnshire, United Kingdom 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...
-
Global Quality and Accreditation Specialist
2 weeks ago
Spalding, Lincolnshire, United Kingdom BSI Full timeAt BSI, we are seeking a highly skilled Global Quality and Accreditation Specialist to join our team.The role of Technical and Regulatory Reviewer is a key position within our organization, responsible for providing medical device quality management system ownership to medical device and QMS audit teams globally.The successful candidate will be responsible...
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