Lead Auditor Medical Devices

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 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

**Job Description**:

- Be able to effectively plan, conduct and lead audits across a wide range of industry sector codes.
- Collate audit / assessment findings, prepare reports and communicate findings to clients to ensure understanding of the requirements and area(s) that need to be addressed and/or corrective action required.
- Provide accurate and prompt information to the Delivery Support Team, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan and schedule your audit / assessment workload to make best utilisation of your own time and maximise revenue-earning activity, performing the duties described above, to ensure that such duties are performed in an efficient and commercially expedient way
- Assist in the training of other auditors and lead auditors during planned training or observation audits or during other training functions and actively in witness audits by SGS or accreditation bodies.
- Maintain and continue to develop audit assessment skills, technical knowledge and participate in ensuring that any Continued Professional Development (CPD) requirements are met.
- Conduct audits (either desk-based or on client’s sites) in accordance with ISO 13485, MDSAP, EU MDD, EU MDR, IVDD, UKCA standards and in conformance with the SGS Global/Local procedures.
- Collecting and analysing sufficient information to provide appropriate recommendations for certifications
- Maintaining a high standard of service delivery that ensures effective customer relationships.
- Complete specific projects related tasks/activities to medical devices procedures, processes, systems and documentation as requested by Program Manager
- Medical Devices

**Qualifications**:

- To be considered for this role, you’ll require a minimum of 4 years of full-time 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, EU MDD, EU MDR standards.
- Experience with Risk Management EN ISO 14971
- Experience with harmonised medical device standards for active & non active devices including Software.

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 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.

**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