[DV-862] Medical Devices Lead Auditor

[DV-862] Medical Devices Lead Auditor

21 Apr
Notting Hill

21 Apr


Notting Hill

Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

We are a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential

We have an excellent opportunity for a Medical Devices Lead Auditor (permanent full-time or subcontractor work) to join our global organisation.

The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDSAP, MDD, MDR and IVDD standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Job Description

Your responsibilities will include, but are not limited to:

- Conduct audits (either desk-based or on client's sites) in accordance with ISO 13485, MDSAP, MDD, MDR, IVDD standards and in conformance with the SGS Global/Local procedures.

- Collecting and analysing sufficient information to provide appropriate recommendations for certifications

- Making relevant decisions concerning the audit process, including informing SGS to resolve audit issues outside the process

- Respond to client enquiries on technical matters

- Report customer complaints, problems and/or system deficiencies

- Maintaining a high standard of service delivery that ensures effective customer relationships.

- 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


- To be considered for this role, you'll require a minimum of 4 years of fulltime professional work experience in the field of medical devices or related sectors (e.g. industry, healthcare, audit or research in medical devices or related area).

- Post-secondary tertiary education or bachelor's degree in one or several of the technical areas e.g. Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical or Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics, Quality Management System etc.

- Successful completion of other formal qualification (advanced degrees) can substitute for a maximum of two years of working experience.

- 2 years of the 4 of relevant professional work experience shall be in quality management. E.g. Quality Manager/Engineer or compliance Manager/Engineer.

- Minimum 4 years of experience auditing for ISO 13485 standard

- Knowledge of auditing for MDSAP, MDD, MDR and IVDD standards and their application.

- Experience with Risk Management EN ISO 14971

- Experience with Harmonised medical device standards for active & non active devices.

Additional Information

We offer an open corporate and international culture, and a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company.

We Support a Diverse Workforce

SGS Australia supports a diverse workforce and providing employment opportunities for Aboriginal and Torres Strait Islander people is an important part of our SGS Reconciliation Action Plan (RAP). We truly believe the diversity among us will continue to foster a strong environment in the workplace. We are an Equal Opportunity Employer and we encourage applications from women and Indigenous people.

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