Medical Device Lead Auditor

vor 3 Wochen

Geneva, Schweiz SGS Vollzeit
Job Description

Primary Responsibilities

As the Medical Device Lead Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards. The Medical Device Lead Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Medical Device Lead Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification. The Medical Device Lead Auditor has the authority for the control and performance of auditing activities including planning and the control of other members of audit teams.

Specific Responsibilities 

Perform audits for clients’ medical devices quality management systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD and MDR. To control as necessary, teams of auditors during the activities covered by items above. Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue. Strive to acquire sufficient audit experience to cover the whole of SGS’s Certification's accredited activities. Assist in the training of other auditors and lead auditors during planned audits or during other training functions. Participate actively in witness audits by SGS or accreditation bodies. Maintain all audit credentials. Undertake any other activities as directed by the Operations and/or Accreditation Manager. As a Lead auditor you are responsible for the overall audit team. Adheres to internal standards, policies, and procedures and performs other duties as assigned.

Qualifications

University or technical college degree in a related discipline (, Medicine, Pharmacology, Biomedical engineering, Microbiology, Biotechnology, Biochemistry, Health technology, Mechanical engineering, Electronical engineering, Quality Management etc.) At least 4 years of experience in the medical device industry Experience auditing for ISO 13485, MDSAP, MDD and MDR standards. Auditor Credentials for either of these standards: ISO 13485, MDSAP, MDD and MDR Ability to demonstrate an excellent working knowledge of medical device management and regulatory systems, standards and compliance/auditing techniques Detailed understanding of the relevant medical device regulations for which audits reviews are being undertaken Effective interpersonal skills; able to develop good working relationships with people at all levels, verbal, written and presentation skills Leadership abilities – ability to Lead a team to achieve a set up goal or complete an audit on time and according to standards Proactive attitude and excellent organizational skills Effectively reacts in stressful situations and make clear, well-founded decisions regarding conformity during the audit Ability to multitask and manage multiple projects while delivering results on time Act with integrity, tact, and character Willingness to learn and adapt to change – committed to continuous personal and professional development Must be IT literate , competent in the use of MS Office applications and preferable experience of using large and complex databases Has working knowledge of English language as well as French

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