Medical Device Auditor with International Expertise

1 month ago

Dongguan, Guangdong, China BSI Full time

Job Description:


We are seeking a highly skilled Medical Device Auditor to join our team at BSI. As a key member of our assessment team, you will be responsible for conducting management system assessments in accordance with BSI requirements.


Key Responsibilities:



  • Undertake management system assessments in accordance with BSI standards and regulations.
  • 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.
  • 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 in your portfolio.
  • 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.
  • Maintain and develop assessment skills and technical and management system standards knowledge.
  • 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".

Candidate Specifications:



  • Bachelor degree or above with medical device related major or an equivalent professional qualification in a relevant subject.
  • A medical device professional with training and a working knowledge of ISO 13485 & EU Medical Device CE Marking, ISO 14971, GHTF Basis Knowledge, Process validation, PMS & Vigilance system.
  • Minimum 4 years working experience in the fields of medical device.
  • Sterilization experience and microbiologist is preferable.
  • IVD background and experience is preferable.
  • CCAA qualification is preferable.
  • Commercial understanding of compliance industry, minimum 2 years quality system management.
  • 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.
  • An enthusiastic and committed team player.
  • Good public speaking and business development skill will be considered advantageous.

Salary: $60,000 - $80,000 per annum (dependent on experience).


About Us: We are BSI, a leading global provider of testing, inspection, and certification services. Our goal is to help organizations succeed by providing independent assurance that meets the needs of customers, governments, businesses, and society.


How to Apply: If you are a motivated and experienced Medical Device Auditor looking for a new challenge, please submit your resume and cover letter for consideration. Note: Interviews may be conducted face-to-face or virtually depending on individual preference.

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