Senior Quality Compliance Engineer / Lead Auditor

Job title: Senior Quality Compliance Engineer / Lead Auditor
Contract Type: Permanent
Location: Glasgow, Scotland
Salary: £43000 - £45000 per annum
Reference: 78109
Contact Name: Ellie Charlwood
Phone Number: 0161 942 2124
Job Published: 1 day ago

Job Description

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
Experience required –
  • 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

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