JOB DESCRIPTION

The successful candidate will perform third-party audits and technical information review in accordance with Versure’s certification procedures and the requirements of ISO 9001, ISO 13485, ISO 13485 under CMDCAS, MDD, IVDD, and/or JPAL. In addition, the successful candidate will:

• Make relevant decisions concerning the audit process and for informing Versure to resolve issues outside the audit process.
• Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities.
• Lead a team of auditors in performing medical device audits, in conformance with the Versure procedures.
• Access and review Indonesian clients’ medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other regulatory requirements for access into Canada, European Union (“EU”), Japan, and review technical dossiers to the requirements of 93/42/EEC (MDD) and/or 98/79/EC (IVDD).
• Determine (upon evidence gained during audits) whether or not manufacturers are in compliance with all relevant standards/regulations, and whether registration should be recommended or allowed to continue.
• Provide technical advice to marketing and sales functions, as required. Utilize and maintain professional communication and presentation skills while meeting with clients.
• Respond to client inquiries on all technical matters regarding Versure certification/training products.
• Report customer complaints, problems and/or system deficiencies to the Country/Technical Manager.
• Assist in the training of other auditors and lead auditors during planned audits or during other training functions.
• Participate actively in witness audits by Versure or accreditation bodies.

REQUIREMENTS

• Must have a Master’s degree in Biomedical Engineering or a related field plus 3 years of experience in the job offered or related occupation, or a relevant Bachelor’s degree plus 5 years of relevant progressive experience.
• Must have 3-5 years of experience (depending on degree) with engineering and technical applications used in the development of medical devices; 3-5 years (depending on degree) of recent and relevant medical industrial or business experience within the medical device manufacturing industry and/or medical device certification industry; solid understanding of Global Regulatory Affairs, including the European Medical Device Directive (MDD); and competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
• Must have at least 12 days of audit experience for Initial Certification (Stage 1 and Stage 2).
• May work from home anywhere in Indonesia.

ADDITIONAL INFORMATION

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
• Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.