Our client, a blue chip medical device company based in Glasgow, is looking for a Senior Quality Compliance Engineer / Lead Auditor to join their rapidly expanding team. They are a world leader in the industry and this is a really exciting role that offers excellent company benefits and career progression. This position will progress to the Head of Quality Assurance so is a fantastic opportunity for candidates looking to use their skills and experience in a management role.
The ideal candidate will have a background within a regulated industry, ideally medical devices or pharmaceuticals, and have proven audit experience. You must have a clear understanding of standards and regulations within the industry including FDA and ISO 13485.
The main duties of the role will include –
- Management and co-ordination of both internal and external audits
- Management of site audit readiness for various inspections
- Maintenance of GMP training materials
- Quality management training
- Ensuring all processes and procedures within the company comply with standards such as ISO 13485, FDA, 93/42/EEC
- Leading the preparation of planned external audits by OEM customers and regulatory bodies
- Developing a process for the management of unannounced audits and responding to any findings of these
- Management of the internal audit schedule and reporting these findings
- A degree (or equivalent experience) in Science / Engineering
- Lead or internal auditor qualified
- Knowledge and experience in a regulated industry, ideally medical devices or pharmaceuticals
- Excellent communication and co-ordination skills
- Competence in the use of Microsoft Office