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    Medical Device Lead Auditor - Zürich, Schweiz - SGS

    SGS
    SGS Zürich, Schweiz

    vor 1 Woche

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    Ganztags
    Beschreibung

    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 German
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