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ISO13485 Medical Device Auditor, Microbiology Preferred

AuditorAuditorFull TimeRemoteSeniorTeam 1,001-5,000Since 1901H1B SponsorCompany SiteLinkedIn

Location

Taiwan

Posted

103 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

ISO13485 Medical Device Auditor, Microbiology Preferred

BSI

• Undertake management system assessments in accordance with BSI requirements • Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision • Recommend the issue, re-issue or withdrawal of certificates • Lead assessment teams as required ensuring quality of service is maintained • Establish and develop an effective partnership with clients to encourage opportunities for business development • Provide accurate and prompt information to support services • Plan/schedule workloads to make best use of time and maximize revenue-earning activity • Coach colleagues as appropriate

Job Requirements

  • Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject
  • Minimum 5 years quality management and technology management working experience
  • Hands-on experience of working as a microbiologist in the manufacture of sterile products
  • Thorough knowledge of Medical Device regulation
  • Knowledge of business processes and the 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
  • Willing to travel on business intensively

Benefits

  • 28 days annual leave
  • Private medical insurance
  • Competitive salary
  • Professional training and development opportunities
  • Flexible working hours

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