Global Quality and Accreditation Certification Lead

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Overview / Purpose of the position:
The role is to provide medical device quality management system leadership to QMS audit teams globally. The role comprises of four main elements:

- Manage the local ISO13485 scheme within ISO 17021, BSI, local, EA and IAF and other applicable accreditation requirements, as well as related regulated schemes (e.g. UKCA/CE).
- Support of the MDSAP and ISO 13485 certification-based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as UKCA and CE.
- Providing policy, input and expertise on medical device QMS audits within existing and developing certification schemes;
- Leading improvement projects.

The position will report to the GQA Technical Manager
- Medical Devices and is home based. Some travel to BSI and third-party locations around the globe for training delivery, accreditor/regulator audits, conferences and business meetings is required.

Responsibilities & Accountabilities:

- Manage the local ISO13485 scheme within ISO 17021, global BSI, local, EA and IAF and other applicable accreditation requirements, as well as related regulated schemes (e.g. UKCA/CE).
- Support the roll out of policy decisions and processes for QMS audits globally.
- Provide support of the MDSAP, ISO 13485 certification and CE/UKCA schemes, by for example, updating procedures, investigating regulator/accreditor non-conformities and customer appeals and supporting activities during witnessed or office regulator/accreditor audits.
- Leading smaller improvement projects and participating in larger projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement.
- Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI requirements for medical devices.
- Provide QMS audit expertise, leadership and mentoring in areas of competence to personnel in the BSI medical devices stream
- Drive the output and quality of QMS audits globally via training development and delivery and report reviewing;
- Coordinate and deliver on at least one of the following: Certification decisions for ISO 13485 certifications as eligible. Competence verifier activities to support the auditor qualification process. MDSAP Report Reviews to Certificate decision teams.

Key Success / Performance Indicators:

- Adherence to specified personal metrics relevant to the tasks where competence is sufficient, for example number of certificate decisions, or report reviews as determined via PDR.
- Maintain and extend local ISO13485 accreditations according to business direction, meeting regulatory requirements with a low level of non-conformities, completing corrective actions in Entropy on time.
- Contribution to team performance metrics, such as report review or certificate decision queue time, enquiry response time, regulator reporting timelines, training delivery effectiveness, etc.
- Completion of project deliverables on time.
- Adherence to both BSI technical and corporate procedures, such as cost management via appropriate expenses management.
- Maintenance of continuing professional development and other learning/development activities

Travel requirements:
Person Specification:
Knowledge and Experience
- A comprehensive 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.
- Ability to understand and interpret legislation and input to policy.
- Broad technical understanding of medical devices and their manufacture.
- Experience of coordinating or conducting audits of medical device manufacturers or certification bodies to ISO13485 (e.g. accreditation, supplier or internal audits).
- Minimum of two years of hands-on manufacturing experience plus two years quality management experience.

Skills and Abilities
- Excellent written and verbal communication, an excellent standard of English is a pre-requisite for the role.
- Strong personal and data presentation skills.
- Good IT skills. Microsoft office & remote meeting platforms essential.
- Ability to engage and consult stakeholders.

Education / Qualifications
- Bachelor’s degree in engineering, science or related discipline.
- Strongly self-reliant and resilient.
- Consultative.
- Confident.
- Equally comfortable working in team roles or independently.
- Good attention to detail.
- Ability to work under pressure of tight deadlines

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.

BSI is conducting face-to-face interviews