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Quality Engineer - Medical Devices

Medical Devices

Berkshire £35k – £45k
permanent Job Ref: 5438


A leading international healthcare company require an experienced Quality Engineer to join its team. You will provide QA support including CAPA, audits, QMS maintenance and customer complaints. It is also essential that you have working knowledge of electrical engineering as you will be required to carry out fault finding on any faulty products.

Essential Job Functions:

• Ensure that products are designed, delivered and maintained with the correct focus on quality and risk, and in compliance with Quality Systems Regulations.
• Provide quality leadership to project teams to ensure that appropriate quality controls and procedures are in place.
• Actively participate in and/or facilitate the development, review and approval of product requirements and specifications.
• Own Risk Management activities; ensure Risk Management Plans are in place and activities are delivered accordingly – i.e. manage the creation of risk assessments; including the definition of suitable mitigation actions and demonstration of appropriate validation.
• Qualify, monitor and audit suppliers; review and / or develop work instructions and quality plans, ensuring correct quality control checks and measures are in place.
• Manage verification and validation activities to ensure that product can be shown to meet all requirements. Generate, approve and/or manage design verification and validation activities.
• Provide support to ensure successful transfer of the design and design controls to manufacturing.
• Identify quality issues and appropriately manage resolution – e.g. assess product failures and implement appropriate non-conformance reports and corrective and preventative actions. Support continuous improvement activities including CAPA investigation, processing and disposition.
• Monitor product quality trends and identify and resolve issues, including full risk mitigation and compliance.
• Ensure that internal servicing, rework and refurbishment activities are appropriately managed and controlled.
• Manage contract manufacture design control to ensure all changes are considered for impact and appropriately validated prior to implementation.
• Create, maintain and update product documentation throughout the product lifecycle (Technical File, Design History File and Risk Management Report).
• Perform all activities in compliance with relevant GMP, internal Quality Systems and safety standards and with FDA Quality System Regulation and ISO 13485
Skills & Experience:

• 3 to 5 years previous experience of working within Medical Device development and working knowledge of relevant requirements of Medical Devices Directive (93/42/EEC, MDR 2017/745), FDA Code of Federal Regulations (21 CFR Part 820) and Canadian Medical Device Regulations (SOR/98-282).
• Experience of Electrical Engineering a must with working knowledge of IEC 60601 and the ability to undertake electrical testing and fault finding.
• Experience of undertaking and managing risk assessments in line with ISO 14971:2012.

Why work for this company?

• A strong, capable individual will progress with promotion.
• You will gain experience in regulatory and product development
• You have full breadth of the organisation globally (rather than a large organisation with a role that will inherently be narrow focused).
• You will have exposure to the CEO and Group Finance Director as well as country General Managers.
• Your ability to identify and solve problems well will be recognised. Value driven people will be rewarded financially.

Salary £35k - £45k

Job Ref: 5438