Global Quality and Accreditation Specialist
4 weeks ago
At BSI, we are seeking a highly skilled Global Quality and Accreditation Specialist to join our team.
The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally.
The responsibilities include:
- Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;
- Supporting in ad hoc improvement projects;
- Technical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.
The ideal candidate should have 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 in particular).
They should also have experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits).
A minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices is required.
Our Excellence Behaviours: Client-centric, Agile, Collaborative.
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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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Global Quality Assurance Specialist
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Chaoyang Qu, China BSI Full timeJob SummaryAs a Global Quality Assurance Specialist at BSI, you will play a key role in providing quality management system ownership to medical device and QMS audit teams globally.Key ResponsibilitiesDevelop and maintain technical expertise in key areas relating to certificate decision making, competence verification, and competence monitoring.Support...
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Chaoyang Qu, China BSI Full timeAs a key member of our team at BSI, you will be responsible for providing medical device quality management system ownership to medical device and QMS audit teams globally.The role comprises three main elements:Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification, and competence...
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Chaoyang Qu, China BSI Full timeAt BSI, we are seeking a highly skilled Technical and Regulatory Reviewer to join our team.Key Role Responsibilities:Develop and maintain technical expertise in key areas related to medical device quality management systems.Support improvement projects and provide technical support for ISO 13485 certification-based schemes globally.Deliver certification...
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Medical Device Quality Specialist
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Quality Assurance Specialist
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Chaoyang Qu, China BSI Full timeJob Title: Technical Specialist and Scheme Manager (Microbiology)Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for a new challenge?BSI is seeking qualified and experienced industry microbiologists to help clients navigate compliance within areas of sterilization, packaging, and microbiological testing.In this role, you will...
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