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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:
The role is home based. Travel is expected for supporting of training delivery, attendance at regulator/accreditor audits and for individual training requirements. Additionally, opportunities should be taken to attend or speak at events that will support continuing professional development. Typically this should constitute no more than 20% of your time, although this may initially be higher during the initial learning phase of the job role. The candidate should hold and maintain a valid passport.

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.
A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements.
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
Desire candidate who has Notified Body background .
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
Remote job and local hire.

其他信息
语言要求：英语

所属部门：GQA