Medical Device Lead Auditor

vor 3 Wochen

Zurich, Schweiz SGS Vollzeit

**Company Description**
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97’000 employees, SGS operates a network of over 2 650 offices and laboratories around the world.

**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 (i.e., 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
- Has working knowledge of English language as well as German

**Additional Information**
Please submit your CV, Cover Letter and Certificates. Thank you.

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