Four Supply Chain

Quality & Regulatory Specialist

Quality & Regulatory Specialist

Independent Manufacturing business

Bootle based - fully site based role (Flexible working available)

Salary - Up to £40k

Independent world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing are looking to secure an additional Quality specialist to their already established team of 4.

Reporting into the Quality Assurance (QA) Manager this is a succession opportunity for someone wanting to develop within Quality Assurance in a leading 'best in class' business.

Key Accountabilities

• The Quality and Regulatory Specialist will work closely with Quality Assurance Manager and assist in ensuring that all aspects of Group Quality Management system remain effective.
• Assist in maintaining compliance with all applicable Quality standards regulatory and statutory requirements necessary to the continued business activities of the Group.
• Assist in ensuring that all documents and information relating to customer regulatory requirements are generated and available as required.
• Investigate and rapidly resolve all complaints relating to Group products and services, ensuring that the necessary corrective and preventive measures are identified, documented, logged and actioned in a timely manner, in accordance with the Group Quality Management System (QMS) requirements and appropriate regulatory requirements.
• Work with R&D staff in the compilation / storage and accessibility of regulatory required product Technical Files.
• Provide support and advice to Company departments in regulatory matters, as required.
• Assist with promoting the principles of regulatory requirements to all staff in conjunction with the QA & QARA Managers, under the overall direction of Top Management (Mast Company Directors).

Day to Day

• Audits, Document Control, Non-Conformance, Supplier Approval etc.
• Identify, as required, all relevant statutory regulatory requirements relating to design, manufacture and sale of Mast's in vitro Medical Device products in any country worldwide and advise the International Sales team of these requirements and any resources required to meet these requirements.
• Assist QARA Manager final sign off of Quality Control documentation as a 'Person responsible for regulatory compliance' in accordance with EU IVD Medical Device Regulation 2017/746.
• Ensure that all documentation relating to compliance to animal bi-product regulations are received for applicable raw materials.
• Ensure that all required aspects of Mast's Quality Management Systems are implemented, controlled and managed in accordance with applicable International Quality Management standards.
• Work with Research and Development, and Quality Control staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
• Working as part of the QARA Team to provide support and advice to Company departments in regulatory and quality assurance matters, as required.
• This includes equipment calibration and monitoring: process verification and validation; document training; Investigation and rapid resolution of complaints relating to Group products; recall and vigilance reporting and liaison with National Competent Authorities as required; ensuring that necessary improvements and corrective and preventative (CAPA) measures are identified and implemented; Internal audit scheduling.

What does the successful candidate look like?

• Good understanding of Quality Management systems such as ISO 13485, ISO 9001, ISO 17025
• Ability to investigate and rapidly resolve customer complaints relating to products and services, maintaining excellent written and electronic records of all related activities
• Ability to plan and prioritise own workload.
• Able to demonstrate excellent communication skills, with internal and external customers, both written and verbal.
• Computer Literate (Microsoft and other packages).
• Experience of formal techniques of problem solving such as Risk based thinking, corrective and preventative actions, root cause analysis.
• Ability to work on own initiative or as part of a team
• Report writing and Presentation skills.
• Experience in auditing procedures and systems
• Excellent administration and organisational skills

Knowledge and understanding of diagnostic microbiology and diagnostic products / Laboratory experience is desirable however, the business will happily consider candidates from a manufacturing and production focused background

This is a fantastic opportunity to join a business during a period of growth and development

Apply online      or call us on     01204 326 444