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Quality Manager job in Cambridge

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Job Ref:  68572086
Employer:  My Job Matcher
Country:  United Kingdom
City:  Cambridge
Post Code:  CB1
11/10/2016 16:33
Are you a Quality Engineer or Manager with experience of quality standards involved in design, development and manufacturing of medical and non-medical devices and software, including FDA, ISO 13485, IS0 9001 or EN NA is an excellent opportunity to establish yourself in a fully autonomous position with a industry leader offering a generous package and excellent career prospects. The company itself prides themselves on their technical expertise in there specialist field. The successful candidate will possess strong technical knowledge, hold a high level of integrity, be self-driven and a high attention to detail. Main Responsibilities:*Ownership of quality related activities within the business.*Establish and lead the Quality Management of NPI activity's*Keep the appropriate teams informed of the quality status of all projects*Manage, review and approve all quality documents, procedures, specifications, non-conformance/events, protocols, reports, technical memos and change controls.*Manage and communicate issues between appropriate stakeholders i.e. Logistics, Engineering, Technical Support, Regulatory Affairs, etc. *Lead regulatory visits, corporate audits and vendor audits *Ensure all existing approvals are maintained, where necessary, submit compliance documents*Ensure personal and company compliance with all necessary regulations, policies, and procedures for health, safety, and environmental compliance. *Produce development project Quality Plans*Lead the quality aspects of design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. *Lead Escalation of Delays, Rejections and Non-Compliance to Standards. *Ensure Device quality assurance meets project timelines. *Lead and manage the other member(s) of the Quality team via the setting of objectives with a strong focus on performance management and personal development in line with the needs of the NA Required:*Proven related experience in the medical device, pharmaceutical and/or biopharmaceutical industry. *Knowledge of device design, process engineering, and/or manufacturing *Knowledge of clinical trial software regulatory requirements including but not limited to 21 CFR Part 11 & GCP*Proven experience in implementing, managing and maintaining ISO 13485, ISO 9001 and EN 60601*Knowledge of quality standards involved in design, development manufacturing and marketing of medical and non-medical devices and software, including but not limited to FDA, ISO 13485, IS0 9001 and EN 623054
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