Senior Quality Compliance Specialist - Blackpool
Emily Mills is recruiting for a Senior Quality Compliance Specialist to join a company in the Medical Devices industry at their site based in Blackpool on a 12 month contract basis.
The Company: Our client has one of the world's most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
The Location: The role is based at our client's site in Blackpool which is easily accessible by car via Junction 32 of the M6 or the M55 which will lead you almost to the beach. Blackpool train links include direct routes to Preston, East Lancashire, London, Manchester, Liverpool, York, Birmingham, Glasgow and Edinburgh.
The Role: Part of the Quality Operations Compliance team reporting into the Compliance Manager with a dotted line to the Quality Systems Manager. This role provides Compliance and Quality Systems support to the site. This includes the procedures and records required for the development of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive
Main activities include:
- Responsibility for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Ensuring that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
- Managing & maintaining Internal Audit schedule by agreeing annual requirements with QA Ops Compliance Manager & QS Manager
- Performing Internal Audits to schedule and complete audit reports and effectiveness reviews.
- Leading the external audit inspection readiness program for the site.
- Providing Front Room/ Back Room support during external audits
- Managing the response process for all external audit commitments. (From creation to closure)
- Implementing harmonized company Compliance Standards and SOPs
- Generating monthly and quarterly quality reports for review by senior and executive management, including the input to monthly dashboards, CAPA reviews and Operational or Executive Management Review meetings.·Generating such data as is required for Dashboard monthly reviews; Act as site EtQ administrator.
- Identifying and implementing Lean projects as applicable to Compliance activities
- In depth knowledge of Good Manufacturing Practice
- In depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs
- ISO 13485 Lead auditor trained.
- Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations
- Experience of conducting validations
- Lean Manufacturing application.
- 6 Sigma Green or Black trained
For more information or to apply for the Senior Quality Compliance Specialist, please contact Emily Mills on 01246 457710 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45046 in all correspondence.