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    QMS Assessor- Medical Devices- Mexico - Ciudad de México - BSI Group

    BSI Group
    BSI Group Ciudad de México

    hace 1 semana

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    Descripción

    QMS Assessor- Medical Devices- Mexico page is loaded

    QMS Assessor- Medical Devices- Mexico

    Apply locations Mexico City time type Full time posted on Posted Yesterday job requisition id JR

    Great that you're thinking about a career with BSI

    Do you believe the world deserves excellence?

    BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.

    Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.

    Overview

    This role is to act as a 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 candidate must be located in Mexico City and be willing to travel at a minimum of 70% of the time.

    Essential Responsibilities:

    • Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
    • Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate
    • Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
    • Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth.
    • 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.
    • Provide accurate and prompt information to 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.
    • 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
    • Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.

    Education/Qualifications:

    • Associate's degree or higher in electrical, mechanical or bioengineering or related degree required
    • Minimum of 4 years experience in medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience.
    • The candidate will develop familiarity with BSI systems and processes as they go through the qualification process.
    • Knowledge of business processes and application of quality management standards.
    • Good verbal and written communication skills and an eye for detail.
    • Be self-motivated, flexible, and have excellent time management/planning skills.
    • Can work under pressure.
    • Willing to travel on business intensively., this is not a home-office or remote position, it is a field based position.
    • An enthusiastic and committed team player.
    • Good public speaking and business development skill will be considered advantageous.
    • Must be bilingual in English & Spanish

    Please submit your resume in English.

    What we offer:

    BSI offers a competitive salary, group-sponsored health and dental, and other various benefits depending on the country

    #LI-REMOTE

    #LI-MS1

    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 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.

    About Us

    BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

    Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
    Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
    BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

    #J-18808-Ljbffr
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