Medical Device Lead Auditor (100%) based in Geneva

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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