Medical Device Auditor

Company Description

We are delighted that you're thinking about a career with SGS

We currently have an exciting opportunity at SGS for a **Medical Device Auditor - Sterile Services **to join our highly successful certification division.

SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is 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.

At SGS, we have an open corporate and international culture, we offer 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.

**Our business principles include**_: Integrity, Health, Safety & Environment, Quality & Professionalism. Respect, Sustainability and Leadership_**

**Job Description**:

- ** Job Title: Medical Device Lead Auditor - Sterile Services Department (SSD)**:

- ** Job Type**:Permanent
- ** Hours**: 37.5 hours per week
- ** Job Location**:Field based (South Midlands mainly)
- ** Travel**:Within UK. Company car or car allowance provided
- ** Salary**: Competitive salary
- ** Benefits / perks**:Generous** **annual bonus, Private Medical Cover, 4-8% matching company pension contributions, 4x Life Assurance, 25 days Annual Leave (increasing with service) plus bank holidays, Birthday Leave Scheme, Enhanced maternity/paternity and adoption pay, Length of Service Awards, Health & Wellbeing initiatives, Christmas Vouchers.

We have an excellent opportunity for a Medical Device Lead Auditor to join our global organisation. You'll plan and conduct professional management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet SSD customer requirements and appropriate accreditation standards

Key Accountabilities:

- Support the training of new Sterile Services Department (SSD) only Auditors to include observation and training during SSD audits
- Support the development of existing auditors to obtain additional simple and complex code approval for on-site auditing at SSDs
- Conduct audits at SSD client’s sites or remotely, in accordance with established procedures, to meet applicable regulatory requirements & those of other applicable stake-holders, in order to maintain a high standard of service delivery that ensures effective customer relationships
- Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business
- Complete specific SSD projects in relation to medical device procedures, processes, systems and documentation as requested by medical devices operations manager

**Qualifications**:
A minimum of 4 years of professional experience in relevant field of healthcare products or related activities e.g.:

- Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
- Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
- 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.
- Work experience in positions with significant QA, Regulatory or management systems responsibility
- Experience with UKCA and SSD guidance, Standards and regulations for non active devices
- Experience with Risk Management EN ISO 14971

In addition:

- Experience of working under own initiative and in planning and prioritising workloads.
- Full driving licence for use in the UK.
- Good English written and verbal skills.

Additional Information