Job Description

JOB DESCRIPTION: We are seeking a Lead Auditor (Medical Devices) to join our dynamic, enthusiastic and expanding team. The role will involve: \xe2\x80\xa2 Conduct audit and training as per medical device requirement. Example:ISO 13485, GDPMD, Conformity Assessment by Way of Verification, Full Conformity Assessment \xe2\x80\xa2 Client Management and promotion of MEDIVICE services \xe2\x80\xa2 Lead audit team when audits and conduct audit for initial and surveillance audit in a professional manner. \xe2\x80\xa2 Ensure that MEDIVICE Procedures are followed for relevant product under their expertise. \xe2\x80\xa2 Provide market information to the management team on new market trend and business opportunities. \xe2\x80\xa2 To carry out customized audit as required by MEDIVICE Management \xe2\x80\xa2 To carry out any additional task as required by MEDIVICE Management \xe2\x80\xa2 Conduct training course under their specialty. \xe2\x80\xa2 Applies judgement and acts according to the MEDIVICE standards of ethics and integrity Requirements \xe2\x80\xa2 Degree in Chemistry/Biology/Microbiology/Biochemistry/Pharmaceutical/ Electronics/ Electrical/ Mechanical Engineering. \xe2\x80\xa2 5 years full time working experience in R&D and /or QA in relevant industries. \xe2\x80\xa2 Preferably has attended ISO 13485 and ISO 9001 Lead Auditor course and has auditing experience \xe2\x80\xa2 Knowledge of relevant Medical device regulatory requirement will be mandatory. \xe2\x80\xa2 Good communication skills, negotiation and interpersonal skills. \xe2\x80\xa2 Acts quickly and decisively. \xe2\x80\xa2 Be able to work independently with high level of initiative and resourcefulness \xe2\x80\xa2 Self- motivated, meticulous and committed, individual who can work well under pressure and with tight deadlines.
OUR COMPANY Medivice Certification Sdn Bhd (Reg. No.: 1270270-V) was established in Kuala Lumpur in March 2018. We provide organizations worldwide with auditing and certification services towards international management system standards particularly for Quality Management System (ISO 13485, ISO 9001), Medical Device Assessment and Professional Aesthetician Certification. Our objective is to provide competent, reliable and credible certification services to organizations, to assist in meeting their business objectives and continual improvement. OUR MISSION To provide competent, reliable, credible and efficient certification services. OUR VISION To be the leading certification body in the global market.
Bachelor\'s or Equivalent