Job Description
Kinetic is working with a leading Medical Device company who are hiring a Senior Quality Management Specialist for their Kingston-upon-Hull office.
Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.
The main responsibilities will include but not limited to:
- Maintain, implement, and improve the Quality Management System ensuring compliance with applicable regulations and standards.
- Lead internal audits and coordinate external audits.
- Support continuous improvement initiatives to strengthen the Quality Management System and enhance operational efficiency.
- Liaise cross-functional teams to identify, investigate, and resolve quality issues in a timely and compliant manner.
To be successful, you will need to meet the following:
- Bachelor’s Degree in Quality, Science, Engineering or business management.
- Minimum 3 years of experience in quality assurance within the Medical Devices/Pharmaceuticals industry in the UK.
- In-depth knowledge of GMP, ISO standards (9001, 13485), FDA QSR, EU MDR and global guidance documents.
- Experience with CAPA, change control, risk management, and validation activities.
- Excellent communication, analytical, and organizational skills.
- Applicants should be available for face-to-face interviews in the location mentioned above.
- Applicants should be available for face-to-face interviews in the location mentioned above.
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