Are you looking to work for an exciting MedTech company making real headway in the medical imaging market? This Quality Engineering role will be responsible for supporting the Product delivery (R&D) teams, ensuring that all product development activities (design and test, from design input through to closure of design projects into the DMR) are compliant with the company’s procedures.
• Attending project development meetings, design reviews etc.
• Reviewing and approving project plans and schedules to ensure that required work and documents are scheduled to be developed.
• Reviewing and approving design specifications, architecture documents, software FMEAs, test plans and reports to ensure development activities are being performed in conformance to relevant SOPs, standards and plans.
• Performing audits internally and with external third-parties to ensure and document requirements are met.
• Raise non-conformance reports (NCRs) and assist in the execution of corrective actions (CAPA) as required.
• Assist colleagues with the facilitation of design change control and its implementation into production.
• Maintain and improve QMS procedures as required. Identify, monitor and report of patterns and trends for QMS related issues.
• A degree in a scientific or engineering subject.
• 5+ years-experience with quality engineering or management within an ISO9000 or (preferably) ISO13485 certified environment.
• Detailed understanding of IEC62304 is strongly preferred.
• Understanding of risk management is required, experience with working to ISO14971 is preferred.
• Experience of working in design and development (quality design and engineering).
• Experience of development of medical devices would be preferred.
Full job description and company details are available upon application, apply below. This position is being dealt with by Nathan Berkley at Meet, please call 0203 019 6020. You can also e-mail us directly at email@example.com to discuss in confidence.
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