BSI Group

  • QA Auditor - Healthcare (Medical Device)

    Contract Type
    Perm Full-Time
    Closing Date
  • The Opportunity

    BSI is seeking a qualified ISO/13845 Quality Assurance Auditor.  The individual will be responsible for delivering BSI’s 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.  The ideal candidate must have “hands on” manufacturing experience in the medical device or related sector and knowlwdge of quality management 


    Essential Responsibilities:


    • Undertake management system assessments in accordance with BSI requirements and Our Client Promise

    • Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and, where appropriate, clear direction to particular items of corrective action

    • Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame

    • Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team

    • Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients

    • Provide accurate and prompt information to client support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met

    • Plan/schedule workloads to make best use of own time and maximize revenue-earning activity

    • Coach colleagues as appropriate, especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested

    • Ensure that value is added to customers and their business/organization through the excellent delivery of BSI training courses/solutions and assessment services, continually enhancing the reputation and perception of BSI with customers and other key stakeholders

    • Proactively engage with peers and key stakeholders to ensure continual improvement, in line with the BSI standards of excellence for training delivery

    • Provide technical support to clients through business development, sales and customer service staff

    • Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.


    About BSI

    Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business.  BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.


    With around 4,000 employees working with over 80,000 clients in 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.


    Our Vision: "To be the global business improvement partner of choice."

    Our Mission: "To help organizations embed excellence", and states our shared purpose.

    Our Values: "Integrity - Continual improvement - Inclusivity", guide us in the way we work and help us deliver our Vision and Mission.


    What we offer:

    BSI offers a competitive salary and bonus. 


    BSI is an Equal Opportunity Employer and we are committed to diversity.

    About You

    This great opportunity for an ambitious professional to gain visibility within the organization. We seek someone who meets all of the following criteria:


    • Hold a minimum of degree level qualifications, or equivalent, relevant to medical devices. For this role this would need to be in Electrical / Electronic Engineering or a closely related subject. These qualifications might be in; electrical, mechanical or bioengineering / biology or microbiology / chemistry or biochemistry / computer and software technology / human physiology / medicine / pharmacy / physics or biophysics

    • Knowledge and experience in the Medical Devices industry is vital. You’ll have a minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management

    • Full time hands-on direct work experience can be in one or more of the following:
          Research and development, manufacturing, service;
          The application of the device technology and its use in health care services and with patients;
          Testing the devices concerned for compliance with relevant national or international standards;
          Conducting performance testing, evaluation studies or clinical trials of the devices

    • Commercial understanding of the compliance industry essential

    • Proven planning, organizing and administrative skills, with the ability to meet deadlines and manage customer expectations

    • Excellent interpersonal skills as well as strong verbal communication and written report writing skills

    • Confident, able to communicate with all levels within a business
    • Be self-motivated and flexible

    • Ability to work under pressure

    • Willing to travel on business intensively

    • An enthusiastic and committed team player

    • Passionate about delivering an excellent client experience through delivery of assessment & training services

    • Computer literate with strong abilities in Word, PowerPoint and Excel in particular

    • Ability to demonstrate BSI’s Excellence behaviors – Accountability, Customer Focus, Respect, Communication, Achievement & Leading and Managing others




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