Quality Assurance Specialist

Job Description:

Aim of Role:

• To coordinate the activities required to ensure all statutory and internal quality procedures and policies adhere to the company’s quality management systems and that they are continually being improved.
• Provide internal audit support & drive improvements in processes.
• Writing procedures and identifying gaps in existing QMS.
• Provide quality and compliance support and administration service for the effective functioning of the quality management system and provide guidance to others if required.

Responsible to: Technical Director

Customer Responsibilities:

• Co-ordinate the documentation and the follow up investigations leading to closure of active Non-Conformities and Distributor/customer complaints (and associated CAPAs)
• Review and investigate customer complaints and non-conformities and ensure timely close out.

Quality Responsibilities:

• Provide Quality and compliance support and administrative service for the effective functioning of the Quality Management System and provide guidance to others if required.
• Run internal audit program including in-process audits.
• Develop and maintenance of all quality assurance procedures and policies to ensure that legal and accreditation requirements are met, in line with rules and guidance for Medical Device manufacturers and accreditation bodies (MHRA, EN ISO13485, ISO9001).
• Perform a non-technical review and make non-technical corrections on the electronic quality system documentation.
• Provide documentation control assistance to manufacturing as appropriate.
• Coordinate the actions agreed in internal and regulatory bodies audit reports
• Assist with the maintenance of the electronic QM System, including monitoring progression of open projects and providing full assistance in achieving closure on time.
• Ensure all routine checks on calibration, equipment and services are being performed.
• Monitor equipment effectiveness and associated communicate costs.
• Maintain approved suppliers and contractors lists and associated risk assessments.
• Ensuring artwork and literature meet regulatory and customer needs.
• Provide/review regular progress report of outstanding complaints, CAPA and non-conformances. Provide assistance in analyzing trends of complaints by category and help in investigations.
• Support/provide any practical training required in support of agreed actions.

Quality Responsibilities:

• Responsible for the development and implementation of the company's quality control and assurance systems.
• Responsible for ensuring the quality of all products.
• Primary contact with MHRA and Notified Bodies.

Regulatory Responsibilities:

• Part of the Person(s) Responsible Team for official communication and regulatory compliance

Other Duties:

• Deal with basic manufacturing issues as required
• Understanding of product characteristics and product mix.

Health and Safety Responsibilities:

• Responsible for reporting health and safety issues seen to Managing Director
• Responsible for observing the company health and safety policy

Plus such other duties as may be reasonably required by the company

Experience:

Previous experience in a similar role is essential.

Experience of working with Medical Devices and/or ISO13485 is required.

Salary is according to experience.

Please note that due to volume of applications, only shortlisted candidates will be contacted.