My Client is seeking a Quality Assurance Manager to be responsible for the day to day running of the Quality Management System in our world class medical devices development consultancy. This includes verifying compliance with company policies, practices, procedures and work instructions, through continued surveillance of an ISO 13485 compliant Quality System to supporting the maintenance and continuous improvement of the QMS to drive business improvement.
• Support development of the QMS to adhere to ISO 13485:2016
• Own and lead pragmatic application of the QA process
• Manage the internal audit process, including facilitating third party audits
• Implement continuous improvement through leveraging of best practices and benchmarking against industry leaders to ensure the company’s quality system is world class
• Update and maintain all quality related documentation and processes
• Train and coach staff on current QMS and any future changes, including conducting new joiner inductions
• Investigate non-conformance, manage and verify corrective and preventive action
• All other QA related activities expected of a management position within a fast-growing SME.
• HNC / diploma in quality or relevant degree, e.g. in engineering or science
• Demonstrable experience in quality assurance
• Knowledge of ISO 13485 and Medical Device Directive
• Experience in combination drug delivery and medical device product development would be advantageous.
• Excellent communication skills, including high quality document preparation, being able to construct persuasive arguments and demonstrating active listening skills
• Ability to liaise with colleagues, clients and sub-contractors at technical and non-technical levels, as well as all levels of seniority.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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