ABOUT THE ROLE
Reporting to the Quality Assurance Manager, the Company Auditor will provide direct resource in delivering the Internal Audit programmes of the Northern Ireland sites (Comber and Coleraine). The Company 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.
- Schedule and conduct Internal Audits in line with plans for the Northern Ireland sites.
- 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.
- 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.
- 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.
- 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
- Quality & Regulatory, Operations and Supply Chain
- Notified Bodies & Competent Authorities
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail.
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively.
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.