Lead Auditor

3 weeks ago


Petaling Jaya, Malaysia MEDIVICE CERTIFICATION SDN BHD Full time

JOB DESCRIPTION: We are seeking a Lead Auditor (Medical Devices) to join our dynamic, enthusiastic and expanding team. The role will involve: - Conduct audit and training as per medical device requirement. Example:ISO 13485, GDPMD, Conformity Assessment by Way of Verification, Full Conformity Assessment - Client Management and promotion of MEDIVICE services - Lead audit team when audits and conduct audit for initial and surveillance audit in a professional manner. - Ensure that MEDIVICE Procedures are followed for relevant product under their expertise. - Provide market information to the management team on new market trend and business opportunities. - To carry out customized audit as required by MEDIVICE Management - To carry out any additional task as required by MEDIVICE Management - Conduct training course under their specialty. - Applies judgement and acts according to the MEDIVICE standards of ethics and integrity Requirements - Degree in Chemistry/Biology/Microbiology/Biochemistry/Pharmaceutical/ Electronics/ Electrical/ Mechanical Engineering. - 5 years full time working experience in R&D and /or QA in relevant industries. - Preferably has attended ISO 13485 and ISO 9001 Lead Auditor course and has auditing experience - Knowledge of relevant Medical device regulatory requirement will be mandatory. - Good communication skills, negotiation and interpersonal skills. - Acts quickly and decisively. - Be able to work independently with high level of initiative and resourcefulness - 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



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