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Senior NPI Quality Engineer

TEC PARTNERS LIMITED
Job LocationNorfolk
EducationNot Mentioned
Salary£50,000 - £65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

TEC Partners are working with a leading Medical Device Manufacturer in East Anglia, who are looking for a Senior Quality Engineer to manage quality requirements within their NPI Programmes. Youll work closely with internal project teams, and the wider group, to plan and execute the design and development stages for NPI Programmes, whilst adhering to ISO13485 and FDA stage gate review process.Ensure that the processes and system for NPI programmes is clear, adhered to and compliant with relevant external regulations and standards. Reduce risk where possible by applying and maintaining comprehensive stage-gate controls, then work closely with operations teams to transition NPI products effectively.Job Responsibilities:

  • Identify, define and manage deliverables for design control validation and risk management activities within the NPI programmes to ensure product quality and compliance.
  • Provide oversight of quality elements within the product lifecycle, working closely with internal functions, customers, regulatory bodies and suppliers.
  • Conduct independent reviews and approvals to ensure compliance with input documents, human factors, ISO 10993 testing, ISO 14971 - Risk assessment files, reliability requirements and Essential Performance Requirements (EPRs).
  • Develop relationships with internal and external customers to provide regular updates on programme stages associated with quality and provide specialist technical advice where necessary
  • Keep abreast with current quality and regulatory requirements that could affect the whole product lifecycle for medical devices/combination products.
  • To write & approve documents required for the MDF/DHF Technical File, as well as protocols & reports for NPI stages.
  • To review & be responsible for releasing NPI product for clinical trials, validation, verification testing etc. in accordance to the customer specifications and regulations.
  • Provide leadership and direction to all direct reports ensuring personal development plans and succession planning pipelines are in place and regularly reviewed and that a culture of continuous learning is promoted and maintained.
  • To ensure that NPI products are guided through the stage-gate NPI system and are transferred into Operations effectively and smoothly.
  • To identify and implement continuous improvement through the lifecycle management of the product
    • Essential Job Requirements:
  • Proven experience in a similar role within Quality Engineering - gained either in a Quality or NPI environment.
  • Knowledge of design control, human factors, clinical trials and risk management requirements for medical device/combination products.
  • Experience with early stage design quality.
  • Good working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, ISO 10993, GMP (Orange Guide), MDD/MDR.
  • Proven demonstration of teamwork & driving results through a team based approach.Experience/ability to influence decisions and all levels of the business.
    • Desirable Job Requirements:
  • Exposure to or experience in working with Six Sigma methodology/tools
  • Previous experience working with SAP
  • Working knowledge of statistical tools
  • Ability to problem solve, provide solutions and use analysis to provide solutions
  • Previous experience of managing small teams, either direct line management or in project teams
  • Educated to degree level
    • This business have done exceptionally well recently, and grown massively over the last few years. They are keen to recruit a seasoned professional, and are willing to pay very competitive packages to secure the right candidate. Generous relocation packages are also available.If this role sounds of interest, please get in touch with Jamie Fisher at TEC Partners directly.

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