LRQA

Medical Device Auditor, ISO 13485

LRQA

full-time

Posted on:

Location Type: Office

Location: Cape Town • 🇿🇦 South Africa

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Job Level

Mid-LevelSenior

About the role

  • Within authorised area of specialism, undertake business assurance assessments in accordance with current procedures and agreed timescales.
  • Lead assessment teams effectively, ensuring that the visit is completed within the agreed timescales, and co-ordinating team findings to reach conclusions.
  • Produce high quality assessment reports reflecting business assurance principles in compliance with accreditation requirements and internal procedures.
  • Ensure that all internal client stakeholders are kept informed of changes and issues, escalating as appropriate.
  • Pass opportunities and sales leads to appropriate colleagues to progress.
  • Pass client feedback and insights to appropriate internal recipients.
  • Maintain professional competence by keeping abreast of technical and other developments in own area of expertise, maintaining CPD records, updating CV, maintaining professional registrations and producing records of competence as required.
  • Actively build strong client and internal relationships.
  • Participate fully in Assessor meetings.
  • Perform additional and ad hoc tasks promptly as required such as assessor development, product development or projects.

Requirements

  • BSc degree, higher diploma or equivalent in one or more professional areas viz. biomedical science, microbiology, chemistry, biochemistry or bioengineering, human physiology, medicine, pharmacy, physics or biophysics
  • In general, a minimum of four years full-time work experience in a medical device related industry, including two years in one or more of the following: research & development, manufacturing, application of the device in a clinical setting, testing of devices for compliance with standards, conducting performance testing, evaluation studies, clinical trials
  • Wider knowledge of ISO 13485 Standard; must have successfully completed IRCA regd. Lead auditor training courses
  • Third-party auditing experience in the relevant sector with an IAF recognized certification Body.
  • Being familiar with relevant International/local laws and industry regulations
  • A good verbal and written knowledge of the local and English language
  • Preparedness to travel when necessary to visit locations abroad
  • Analytic insight and proactive attitude
  • Communicative and social skills
  • Qualification to other schemes e.g. ISO 9001, ISO 14001 & ISO 45001 will be an added advantage
Benefits
  • Diversity and Inclusion at LRQA: We are on a mission to be the place where we all want to work and we are passionate about embracing different perspectives because we understand the value this brings to our business, our clients and each other.
  • We are all about creating a safer and more sustainable future and our inclusive culture is right at the heart of our business.
  • Together our employees make our communities better and we want you to be part of our diverse team!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
business assurance assessmentsassessment reportsresearch & developmentmanufacturingclinical trialsperformance testingevaluation studiesISO 13485ISO 9001ISO 14001
Soft skills
leadershipcommunicationclient relationship buildinganalytical insightproactive attitudesocial skillsteam coordinationstakeholder managementproblem-solvingadaptability
Certifications
IRCA registered Lead auditorIAF recognized certification