Quality Auditor

**ABOUT THE ROLE**

Reporting to the Quality Assurance Manager, the Quality Assurance Auditor will provide direct resource in delivering the Internal Audit programmes of the Northern Ireland operations (Coleraine & Comber). The Quality Assurance Auditor role is key to the success of the Northern Ireland Businesses Regulatory and Quality strategy, ensuring the development and delivery of a Quality strategy.

**KEY ACTIVITIES**
- Schedule and conduct Internal Audits in line with plans for the Northern Ireland sites (Coleraine & Comber).
- Prepare meticulously for assigned audits by creating individual audit plans and provide detailed and consistent audit reports.
- Where non-conformities or Corrective and Preventive Actions arise, take initiative to work with departments to support root cause analysis and implement associated actions to address and verify effectiveness of actions in line with Company Standard Operating Procedures and drive improvements.
- Act as lead auditor, providing guidance and leadership to company auditors on key identified audits.
- Support the Northern Ireland QA team on matters of Compliance, providing guidance where required.
- Represent the Northern Ireland Businesses at all external agency and customer inspections.
- As a member of the Northern Ireland QA team, develop and implement a system for imbedding a QARA culture through the Northern Ireland businesses
- Manage reporting of measuring and monitoring of Key Performance Indicators related to the internal audit process on a monthly basis and for Management Review
- Responsible for ensuring the Northern Ireland Businesses Quality Management System reflects requirements and is kept compliant.
- Review requested QMS Documentation creations, revisions and obsoletions.
- Support Supplier audit schedules, conducting Inspection when assigned.

**Other**
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
- To adhere to the company’s Quality policy and Environmental policy
- To undertake other duties as may be reasonably required.

**KEY SKILLS**

**Essential**
- Previous experience in a Regulated Medical Device Company (ISO13485, MDSAP, EUMDR, EUMDD, UKCA)
- Experience of supporting audits, both as an auditor and auditee
- Strong communication skills, both verbal and written. Organised with an ability to assess priorities and deliver.
- Ability to work independently with confidence.
- Competent In the use of relevant Microsoft packages
- Full UK driving license.
- Experience working within an ISO standard (preferably ISO:13485 (with MDSAP))
- Methodical with analytical and problem-solving skills.

**Desirable**
- IRCA Approved Lead Assessor Qualified with MDSAP auditing experience.
- Experience of interacting with multiple departments of an organisation to provide continual improvement support through the Internal Audit Program
- Knowledge of and experience with CAPA process, including formal root cause analysis.
- Experience of leading audits within a regulated or manufacturing environment

**KEY WORKING RELATIONSHIPS**

**Internal**
- Quality & Regulatory, Operations and Supply Chain

**External**
- Suppliers
- Customers
- Notified Bodies & Competent Authorities

**ADDITIONAL INFORMATION**
- Regular business travel required to Coleraine & Comber.