Medical Devices Trainee Auditor

  • 585 Blackburn Rd, Notting Hill VIC 3168, Australia
  • Full-time

Company Description

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 93,000 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

We have an excellent opportunity for a Trainee Medical Device Auditor to become a Medical device Auditor 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, MDR, IVDR and UKCA standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

KEY ACCOUNTABILITIES
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, MDR, IVDR, UKCA standards and in conformance with the SGS Global/Local established 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
  • Report customer complaints, problems and/or system deficiencies
  • Maintaining a high standard of service delivery that ensures effective customer relationships.
  • Complete specific projects in relation to medical device procedures, processes, systems, and documentation

In the first six months of being a Medical Devices Auditor you will be given full training in auditing medical devices.

Qualifications

To be considered for this role, you’ll require a minimum of 4 years of professional work experience in the field of healthcare products or medical devices or related sectors e.g.: 

  • You'll work in the medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
  • Experience working in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
  • Experience in the application of device technology and its use in health care services and with patients
  • Testing devices for compliance with the relevant national or international standards
  • Conducting performance testing, evaluation studies or clinical trials of devices

2 years of the 4 of relevant professional experience shall be in quality management. E.g. Quality Manager/Engineer, CAPA or complaint Manager/Engineer.

In addition to the above you’ll also need to demonstrate the following;

  • An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
  • Good knowledge of ISO 13485, MDR, and their application.
  • Knowledge of MDSAP, IVDR, UKCA.
  • Work experience in positions with significant QA, regulatory, or management systems responsibility.
  • Experience with harmonised medical device standards and for active and non-active devices.
  • Experience with Risk Management EN ISO 14971.
  • Medical device experience from auditing/work.
  • Experience auditing against recognised standards.
  • Experience of working under own initiative and in planning and prioritising workloads.
  • Solid knowledge of active and non-active devices.
  • University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology etc
  • Full driving license for use in Australia.

Ideal candidates will be those currently living and working within Australia with no restrictions on their working rights.

APPLY NOW

If you believe you can fulfil above requirements, you are encouraged to apply. Please submit a cover letter and resume highlighting your skills and experience. Feel free to refer your qualified colleagues.
 

Additional Information

WHY WORK FOR SGS?
Working at SGS means joining an innovative, global Company. Let’s break down what that means for you.

  • As a Company, we have embraced the shift to flexible work. We encourage our employees, wherever operationally possible, to work in arrangements that support a work-life balance.
  • We’re a Company who believe our impact on society is important, so Sustainability is embedded in our culture and the way we do business.
  • Paid Parental leave scheme for 8 weeks for eligible employees.
  • We are driven to ensure we have a positive impact on our local communities through paid employee volunteering days and regularly encouraging time off to donate blood.
  • Health & Wellbeing is important to us, which is why we offer annual health club membership rebates and discounted private health insurance, as well as a supportive Employee Assistance Program.
  • Ongoing learning & development is vital to the success of any Company. We believe in investing in our employees, so we offer education assistance programs and encourage the use of our online learning platform.
  • Career Development Opportunities (nationally and Globally)

COME TO WORK AND BE 100% YOU
SGS Australia supports a diverse workforce and we encourage applications from people of all ages, nationalities, abilities, and cultures – including Aboriginal and Torres Strait Islander peoples, the LGBTQI+ community and people living with disability. 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, innovative and forward-thinking workplace.

SGS Australia acknowledges and pays respect to the past, present and future Traditional Custodians and Elders of this nation and the continuation of cultural, spiritual, and educational practices of Aboriginal and Torres Strait Islander peoples.

Privacy Policy