QA Medical Devices Specialist

Company:  Parkside Recruitment
Location: London
Closing Date: 04/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
My client is seeking and experienced Quality Assurance professional to join their Global Product Quality team. Role Overview Contribute to the maintenance of the company’s quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and fully complies with all relevant legislation and industry recommended practice. Key Accountabilities Develop and maintain the quality management system to assure compliance with ISO and other applicable device standards, in addition to GMP and GDP requirements Plan, implement and perform internal quality audits. Monitor and report on product non-conformities. Manage and maintain systems for change control, deviation and CAPA. Manage and maintain a system for product complaint handling ensuring timely completion and reporting. Collect, collate and compile data for periodic product quality reviews, including preparation of reports Liaise with regional Regulatory team to ensure compliance with applicable requirements Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures Skills & Experience Pharmaceutical industry experience Experience in management of Medical Device Quality Management Systems Experience in management of product quality complaints Experience of Electronic Document Management Systems Additional relevant QA experience
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