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Austin Vita
,
Oxford, Oxfordshire
Senior Quality Specialist
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Salary: £40000 - £50000 per annum |
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Overview
Senior Quality Specialist £40,000-£50,000 Oxford Austin Vita are working with a ground breaking AI diagnostics imaging company, looking to find the newest addition to their quality team. There is a real focus on development and progression, as they are a relatively young business, with the potential for the Senior Quality Specialist to take ownership of the Quality Management System. Competencies Currently working with ISO13485 standards and FDA regulations Previously engaged with CAPA and investigating complaints. Previously engaged with Quality System documentation. Ideally risk management experience (ISO14971). Ability to effectively manage multiple and changing priorities. Ability to work in a high paced environment. Ability to collaborate to achieve objectives, problem-solve, and meet timelines. Understanding of the software development lifecycle Experience in handling and coordinating responses to FDA and ISO inspections. Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners. Strong communication (written and verbal) and computer skills. A Bachelor's degree in science or engineering with 3-5 years of experience in quality systems/quality assurance in the medical device industry is required. Key Duties & Responsibilities Assist in ensuring compliance with the organisation's policies and all applicable national and international quality standards and regulations (i.e. ISO 13485, FDA 21 CFR Part 820). Assist in the development and maintenance of the document control process. Ensure complaints are investigated. Track CAPAs to ensure appropriate verification, implementation and follow-up on corrective actions. Develop and maintain QA standard operating procedures (SOP). Conduct internal and external audits of the quality system. Collect information related to key QMS indicators and performance, including creation of periodic reports for management. Present at management review meetings information regarding the functioning of and impact of the quality system. Develop and perform QMS training for employees. Identify and recommend opportunities for improvement. If you are an experienced Quality Engineer/Quality Specialist and meet the criteria listed, please APPLY NOW Senior Quality Specialist, Oxford, £40,000-£50,000 Austin Fraser is acting as an Employment Agency in relation to this vacancy. Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status. Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.