GQA Certification Lead

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Job title: GQA Certification Lead

Location: India Homebased

About the role

This exciting 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. The fourth element will comprise of leading improvement projects. The position will report to the GQA Technical Manager - Medical Devices and is home based. 

Responsibilities:

• 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.

• Drive the output and quality of QMS audits globally via training development and delivery and report reviewing.

Travel is expected to support training delivery, attendance at regulator/accreditor audits and for individual training requirements. 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.

To be successful in the role, you will have: 

• Bachelor’s degree in engineering, science or related discipline.

• Minimum of two years of hands-on manufacturing experience plus two years quality management experience.

• Experience of coordinating or conducting audits of medical device manufacturers or certification bodies to ISO13485 (e.g. accreditation, supplier or internal audits).

• 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 good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements.

• Broad technical understanding of medical devices and their manufacture.

• Excellent written and verbal communication, an excellent standard of English is a pre-requisite for the role.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 20-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, meal allowance, paid maternity leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.  

Do you believe the world deserves excellence?

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we’re truly impartial, and home to the ultimate mark of trust, the Kitemark.

Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.

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BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.