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QE _ Medical Devices Cambridgeshire

Vivid Resourcing, ,United Kingdom
Employment type: 
Full time
Engineering, Management, Risk Management

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QE _ Medical Devices Cambridgeshire

Provide oversight of Manufacturing New Product Development/NPI projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level
Have knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
Be able to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
Authors validation, verification, and inspection assessments to ensure the defensibility of product test data. Selects appropriate testing sample sizes based on criticality and statistical calculation.
Supports leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process

Quality Engineer Qualifications include:

Engineering Degree or equivalent experience in medical device industry.
At least 3 years' experience in with Medical Devices.
Experience in Software Validation/Verification for regulated, embedded software/systems and processes.
Experience in Software quality for standalone and embedded software.
Understand risk analysis philosophies, methodologies, and their applications.
Have an understanding of problem-solving and quality improvement tools and techniques.
ISO 13845
Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.

Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.