Job Title: Regulatory QMS Specialist
Job Type: Permanent, full-time position
Location: Bourton on the water, Gloucestershire, UK – Hybrid (3 days on site)
Remuneration: £35,000 - £40,000
An exciting Regulatory QMS Specialist position working for a global leader in the provision of quality medical products. The role will be working across a wide product portfolio, including orthopaedic products.
Responsible for managing the audit program, including internal auditing and supplier auditing. Supporting the Quality Management System, including Quality Objectives and NC/CAPA management.
Role responsibilities:
* Manage the supplier auditing program, including scheduling audits and assigning auditors.
* Perform supplier audits as required.
* Manage the internal audit program, including scheduling audits and assigning auditors.
* Perform internal audits as assigned.
* Provide support during external audits, including collating pre-audit document requests.
* Manage the Quality Objectives procedure.
* Manage the NC/CAPA procedure.
* Provide backup to the RA/QMS Administrator for document control and training activities on MasterControl.
* Continuous improvement - To initiate, support and lead Continuous Improvement projects as required.
Qualifications Required:
* Experience of Quality Systems auditing is essential.
* Experience within the Medical Devices industry is desirable.
* Excellent working knowledge of Microsoft Office (Word, Excel, OneDrive.)
* Excellent written and oral communication skills in English.
This is a great opportunity to join a leading business that specialises in orthopaedic products. Please note that this is a hybrid position that will require 3 days on site per week.
For more information, please reach out to lucy.kirkaldy@cpl.com