Medical Device Auditor

2 weeks ago


Ho Chi Minh City, Ho Chi Minh, Vietnam Bureau Veritas Full time
Our Mission & Ambition are

Shaping a World of Trust. A business to business to Society Company, contributing to transforming the world we live in. Thanks to our nrivalled expertise, technical knowledge and worldwide presence, we support our clients by managing quality, safety, health and sustainability risks, to the benefit of society as a whole. This is what Bureau Veritas is about, truly believing that it contributes to bettering society.

Our Absolutes are

Ethics, Safety and Financial control; and our Core Values are

Trusted, Responsible, Ambitious & Humble, Open & Inclusive. We strongly believe that you are here more than just working, being part of the BV family, it's being convinced that you will "

Leave your markin Shaping a World of Trust".

TASKS - ACTIVITIES - RESPONSIBILITIES

  • Conduct audits and assessments of medical device manufacturers, suppliers, and distributors to ensure compliance with regulatory requirements and quality standards.
  • Review and analyze manufacturing processes, quality control measures, and product design and testing protocols.
  • Evaluate and report on the effectiveness of quality systems and procedures, including identifying and addressing any gaps or areas for improvement.
  • Work with internal teams and external partners to develop and implement corrective and preventive action plans.
  • Provide training and guidance to team members and stakeholders on quality control and regulatory compliance issues.
  • Be able to effectively plan, prepare and carry out an internal audit as per ISO 13485:201
  • Be able to evaluate the significance of audit findings, develop and implement corrective action programs
  • Authority over whatever decisions are necessary during the audits and to recommend the presentation or otherwise of a certificate of approval;
  • To decide upon evidence gained during Audits whether or not certification should be granted or allowed to continue;
  • To represent BV Certification, where necessary, to potential clients and to negotiate in conjunction with other responsible personnel, appropriate contracts.
  • To have the main responsibility for client contact during the audit and for the success of the contract delivery.
  • To refer business and actively participate in identify opportunities for crossselling Bureau Veritas services, as needed.
  • To undertake any other activities as directed by the Certification Manager and/or the Central District System Certification Services Business Line.

CANDIDATE PROFILE**-Technical sectors university degree; Medical is most preferred for ISO13485.

-5 years of working experience with at least 3 year experience in QA, QC, Technical, Production or Management system related;

  • Has successfully completed a registered or IRCA approved Lead auditor course based on reference standards: ISO9001; ISO 14001, ISO13485, etc;
  • Experience of participated to 2nd Parties/ 3rd Parties audit will be a plus.
  • Willing to travel frequently.

TECHNICAL

AND PROFESSIONAL SKILLS

  • Good in reading, writing & speaking English
  • Expertise in using Microsoft Office including Word, Excel, Outlook and Web skills;
  • Proven ability to work in a cross functional and global environment;
  • Can work independently under pressure
  • Effective problem identification and solution skills;
  • Can arrange to travel for inspection jobs


Join an inclusive, flexible, and diverse company where you can thrive while contributing to positively transforming the world we live in.

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