Medical Device Auditor

Great that you're thinking about a career with BSI!

About the role :

The British Standards Institution (BSI) is seeking a Medical Device Manufacturing Engineer interested in becoming a QA Auditor.

This is a home-based role with approximately 60% travel to client sites.

Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous BSI training, our QA Auditors conduct ISO 13485 audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.

The ideal candidate will need hands-on technical experience with medical devices in the following categories : active devices, plastics, and metals.

Medical Device Auditor Responsibilities :

Deliver BSI’s third-party audit services to assigned clients in accordance with all BSI, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs.

Analyze quality systems and assess ISO 13485 and CE Marking

Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements.

Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results

Participate in professional development and training opportunities to achieve necessary certifications and statuses

Education / Qualifications :

Due to strict regulatory requirements, only candidates with Bachelor’s degrees in computer and software technology, biology, chemistry, biochemistry, electrical / electronic / mechanical or bioengineering, human physiology, medicine, physics, or biophysics, will be considered for this role

A minimum of four years of full-time hands-on (R&D, manufacturing, and / or testing) work experience in the field of medical devices or related sectors

At least two years in the area of quality management (experience working in an organization governed by regulations and standards)

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, bank holidays, health, vision, dental and life insurance, pension plan with company contribution, short-term and long-term disability, pregnancy and parental leave, registered savings plan, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.

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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.

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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!

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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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