Business Segment: Healthcare Clinical Care Solutions
Location(s): United Kingdom; Nottingham
About Us: GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. Learn More About Careers at GE
Role Summary: The role is responsible for providing quality engineering support to the Engineering and Operation teams. Ensuring that Quality at all levels are being considered during the design & development and operational activities. In addition, taking an over view to ensure that the Quality Management Processes are being followed though actively reviewing documentation and periodic audits.
Responsible for ensuring 100 percent Quality Management System compliance in accordance with documented procedures for all aspects of the business.
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency.
Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Where required undertake internal audits in accordance with GE processes to ensure compliance to FDA CFR 21 820, ISO13485 : 2016 and MDSAP.
Where required work with subcontract manufactures to ensure all quality, requirements have been met during the manufacturing process and before product is released to market.
Bachelor’s degree (or high school diploma/GED plus proven working experience in Quality Engineering or Quality Assurance Management or equivalent knowledge & experience.
Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO13485 : 2016 and MDSAP.
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.
Significant Multi-Modality Sites: Proven years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
Small and Simple Sites: Some years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
Demonstrated experience using word processing, spreadsheet, and presentation software
Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)
Ability to communicate using English (or local language)
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website http://www.ukba.homeoffice.gov.uk/visas-immigration/working
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