Quality Management Systems Specialist - Hull
CK Group is recruiting for a Quality Management Systems Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Hull for a 6 month initial contract.
The Company: Our client is a company that supports healthcare professionals in over 100 countries in an effort to improve the lives of their patients. The company takes a pioneering approach to the design of advanced medical products and services by securing wider access to their diverse technologies for more customers globally and by enabling better outcomes for patients and healthcare systems. They hold leading positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine to name a few.
Location: Hull is a port city in East Yorkshire, is named as the UK's City of Culture 2017. The city is at the eastern end of the M62 and can be easily accessed from the rest of the UK motorway network. It has good access from Lincolnshire and the south via the A15 and the Humber Bridge, and can be accessed by the A1079 from York and the North.
The Role: This position of Quality Management Systems Specialist will be tasked with assisting in the development, maintenance and co-ordination of the Quality Management Systems (QMS), supporting the implementation of changes to Company Global Policies, Regulations and International Standards into the Hull QMS whilst complying with company Quality Systems and applicable Regulations & Standards, Health & Safety Requirements and Site Safety Policy.
- Develop and manage relationships with personnel in all functions and levels to ensure the delivery of the highest standards of internal and external customer satisfaction.
- Manage workload effectively in order to achieve personal and departmental objectives.
- Show initiative in problem solving by identifying and recommending solutions to problems encountered.
- Ensure professional development of self and personal knowledge of applicable parts of GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices.
Ideally educated to degree level or has equivalent work experience in relevant area. Good working knowledge of company products, processes, procedures and personnel.
Experience working within Quality Assurance, preferably within the Medical Device / Pharmaceutical Industry.
- Awareness / understanding of the Medical Device Directive, GMP, GDP, ISO 9001, ISO 13485, 21 CFR Part 820.
- Strong analytical and good communication skills are essential together with the ability to manage personal workload to ensure high standards are maintained.
- Trained auditor desirable.
- Awareness / understanding of the impact of the department on the business.
- Knowledge of the potential for product liability, alleged adverse incidents and potential - Field Safety Corrective Actions.
- Experience with Excel is essential.
For more information or to apply for this position, please contact Julie on 01438 723500 or email 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 45619 in all correspondence.