Quality Assurance Specialist

We are looking to recruit a highly skilled and conscientious Quality Assurance Specialist to join the team based at our site in Bootle. The job holder will be an integral part of the team, ensuring the effective compliance of quality standards across the business, ensuring professionalism in all that we do. The successful candidate should be willing to actively engage and contribute their technical knowledge, to aid quality assurance and compliance across the business providing effective guidance and advice in line with quality standards and regulatory requirements for the benefit of the mast portfolio of products. 

Mast Group Ltd. are a world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing. As an independent company, since 1959, our commitment to maintaining integrity and customer satisfaction, combined with innovation in in-vitro diagnostics, has resulted in improved clinical decisions and pathways. We recognise our responsibility to provide reliable, fit for purpose in-vitro diagnostics in every community globally.

THE ROLE
• Identify and ensure compliance with ISO13485 and ISO9001standards, and regulations related to IVD medical devices products.
• Ensure compliance across all product manufacturing, marketing and sales areas.
• Development of Quality Assurance procedures.
• Identify nonconformities and corrective/preventive actions.
• Carry out effectiveness checks for corrective/preventive actions.
• Cross departmental collaboration to enable resolution of quality issues.
• Accurate QA document and record management and retention.
• Working with complaints investigations from receipt to successful completion.
• Work with R&D functions to ensure compilation, storage and accessibility of product technical documentation, in line with quality standards and regulatory requirements.
• Work with other departments to provide advice and support in regulatory and quality assurance matters

In addition to the specified duties the Quality Assurance Specialist is expected to perform additional tasks that the QARA Manager/QARA Team Leader may require.

THE PERSON
• Proven experience of understanding and working directly with ISO 13485 and a QMS environment.
• Relevant associated experience in a similar field.
• Excellent understanding and practical use of how a QMS operates
• Knowledge of In-Vitro Device Regulation 
• Experience of preparing and presenting written reports and documentation. 
• Demonstrable experience of problem-solving techniques such as risk-based thinking, root cause analysis etc. 
• Excellent communication skills at all levels, both internally and externally 
• Organised, with a good attention to detail 
• Ability to work on own initiative and plan workload effectively 
• Computer literacy essential for Microsoft and other packages 
• Knowledge of diagnostic products and microbiology
• Understanding of ISO 9001 or 17025 an advantage 
• Life sciences or related degree desirable but not essential
In addition to the specified duties the employee is expected to perform additional tasks when reasonably called upon to do so.