Auditor (Amp)

**Tasks**
- Conducting quality management system audits against ISO 13485
- Managing manufacturer s certification and their conformity assessment projects
- ** Duties and Responsibilities**:

- Work within Active Medical Products (AMP) team as an auditor, performing onsite audits at manufacturer s premises. Audits will be conducted in accordance with the requirements of the EU Medical Device Regulations (MDR or IVDR), and other QMS certification schemes such as UKMDR, ISO 13485 and MDSAP
- Achieve and maintain competency authorisations that are required for the role and within area of technical expertise
- Manage manufacturers and their regulatory projects against various medical device regulatory schemes, such as: CE (MDR, IVDR), UKCA (UKMDR), ISO 13485 and MDSAP
- Operate as a project manager with responsibility for the coordination and management of the different resources on conformity assessment projects, such as, auditors, product specialists, clinical reviewers, and other experts
- Provide technical support the sales team with the generation of quotes and the handling the onboarding for new customers
- Conduct technical documentation assessments of medium or high-risk devices within area of technical expertise and authorisation
- Approximately 40% - 50% travel required for this role. Travel required primarily in UK, Ireland, and EU.

**Qualifications**
- ** Essential Criteria**:

- University degree (B.Sc., M.Sc., or PhD), or equivalent in a relevant science or engineering discipline.
- At least 4 years of work experience with medical devices industry or closely related industries.
- Minimum 2 year working directly with active medical devices.
- Experience should be from: manufacture, production, testing, R&D, quality management systems, or in other institutions carrying out inspections or audits.
- Professional Experience with IEC 60601 and Electrical Safety.
- Strong project management, administration, and organisation skills.
- Methodological, analytical, and critical thinker.
- Strong verbal and written communication skills
- Self-motivating, proactive and must be able to adapt and work in challenging and high-pressure situations
- Ability to be customer friendly whilst maintaining strict adherence to regulatory requirements.
- Willing to undertake frequent travel within the UK, Ireland and internationally
- Full and valid UK driving licence
- ** Desirable Criteria**:

- A good-to-thorough understanding of the EU Medical Device Regulations (MDR/IVDR)
- Knowledge of QMS standards, and/or EU devices legislation