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Cranleigh Scientific
,
Gloucester, Gloucestershire
Quality Assurance Associate
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Salary: £30000 - £35000 per annum |
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Overview
Due to continued growth, an exciting medical device manufacturer requires additional support within its Quality Assurance team. As Quality Assurance Associate, you will take the lead in ensuring key Quality System processes are documented, monitored and maintained in line with business requirements and to ISO13485 regulations. You must have proven experience in a quality assurance based position supporting ISO 13485 QMS systems. Key Responsibilities: To manage all training related issues including employee induction, ongoing training and external training courses. To ensure training records for all employees are complete (in both the employee's files and on the server) and to maintain those records going forward. Support the implementation, monitoring and development of quality assurance processes and procedures. Assist in managing the review, revision and distribution of QMS documentation ensuring effective document control. Provide internal audit support. Undertake quality monitoring activities. Manage and assist with instrument calibration activities. Ensure that calibration documents are constantly and properly updated to make available up to date records of activities for future referencing. Inspect conditions of calibrated measurement and specifications. Assist with safety risk assessments. Assist with supplier quality management. Be responsible person for all company's document archiving activities. Experience Required: Confident understanding and working with controlled and regulatory documents Flexible working with different departments to understand their responsibilities and needs Comfortable with attention to detail and adherence to procedures Proactive approach to managing tasks and seeking opportunities to improve documents and processes Understanding of how to work to the requirements of industry standards and regulations Good experience working with MS Office packages, Word and Excel creating SOP's and work instructions History of working with a document management system Must be comfortable working within small, open teams Previous experience working within a Quality or technical team/department for a medical device or pharmaceutical company Experience working within an ISO 9001/13485 environment or similar Experience/knowledge of cGMP activities EU GCP, GLP, MDR/D or CFR (FDA) exposure would be beneficial Engineering and scientific background preferred GCSE's at grade C or above in Maths, English and a Science subject Any further engineering/science-based qualification