NPI Product and Process Quality Engineer

4 weeks ago

Cirencester, United Kingdom Corin Group Full time

Corin is seeking an accountable and collaborative NPI Product and Process Quality Engineer based in the Global Head Office in Cirencester, Gloucestershire where we design, test, engineer, manufacture, inspect, and distribute our hip and knee implants. This is an office role working 8.30 am – to 5 pm Monday to Thursday, 8.30 am – 4.30 pm on a Friday with an hour for lunch.

We are looking for an individual who has an Engineering qualification as well as time-served engineering experience on the tools and reading drawings within a manufacturing environment, ideally Orthopaedics but automotive or aerospace will be just as valuable with transferrable skills. You will have a compliance and quality head on your shoulders and be comfortable challenging the viability of a design. You will need to have strong Microsoft experience and be confident in Minitab (a comprehensive suite of statistical, data analysis and process improvement tools.)

You will be an NPI Product and Process Quality Engineer who can.

  • Define and develop manufacturing solutions from the early phases of New Product Introduction (NPI) through to production working with our Design Engineers and Production Engineers. It would be best if you had a good understanding of Process Engineering including inspection methods and technologies used to manufacture complex components in a highly regulated environment.
  • Work as part of a project core team to ensure Design for Manufacturing (DFM), Design for Quality (DFQ), and Design for Assembly (DFA) are delivered within a limited period. You will need to be able to make informed decisions based on available evidence and expertise.
  • Work with our operational team (manufacturing and engineering) and external suppliers to develop manufacturing solutions, and processes and specify new equipment purchases as required. You will need to understand lean manufacturing and project management principles.

Corin offers a great benefits package including.

  • A competitive salary and discretionary bonus
  • 25 days holiday plus bank holidays
  • Life assurance at 6x basic salary
  • Pension from 6.7% rising to 9% after 18 months.
  • BUPA for yourself and your family
  • Excellent wellbeing programme
  • Subsidised gym membership
  • Wonderful employee canteen with hot and cold meals
  • Charity engagement with Worthy Cause Wednesdays monthly
  • Great people and products which change people’s lives.

A full outline of your responsibilities as our NPI Product and Process Quality Engineer include.

  • Support the process for the end-to-end manufacture of orthopaedic implants and associated instrumentation with varying degrees of manufacturing complexity within cost and time constraints.
  • Define metrology and inspection methods to support the manufacture of complex devices and systems, including design for quality activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820.
  • Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering/manufacturing problems, as well as supporting the design/development/PPI teams when they are solving issues.
  • Generate and owner of the manufacturing documentation packages to facilitate the transfer to production in collaboration with Development and Production Engineering functions; this includes challenging/creating/filing/maintaining process and inspection sheets, control plans (Internal and External), Goods inwards inspection sheets and any other process/manufacturing related documentation together with gauge and fixture drawings as required. Create your own Engineering Change Request and progress independently.
  • Support the generation of manufacturing, process control, validation, risk management and technical documentation according to Corin's internal procedures ensuring the required quality standards. Identify process risks and help develop solutions to mitigate the risks.
  • Create protocols for the measurement of key component features by the required standards and document the results and conclusions in the corresponding reports.
  • Process stability and capability - Analysing process measurement data using software to determine if key product features are capable and within control limits. Producing reports to communicate the results to key project stakeholders in readiness to transfer to manufacture.
  • Take an active part in the Project Core Team as a Process Engineering expert including Development Engineering, Manufacturing and Production Engineering; liaising with Corin divisions, as required, to ensure the effective introduction of new devices and compliance with regulation.
  • Deliver project presentations at all levels in the organisation as well as to customers/suppliers and Key Opinion Leaders.
  • Mentor and coach other members of the Process Engineering enabling them to progress their skill base.
  • Provide training to operators and inspectors on how to inspect key product features during the manufacturing process. Generation of training documentation to support Team Member development.
  • Create First Article Inspection documentation for internally or externally manufactured orthopaedic components and manage the execution of this task with key departments within Corin.
  • Self-manage the Process Engineering phase of a project within the orthopaedic field where the manufacturing process is characterised by high process complexity, risk, and innovation; this includes CAPA projects as well as NPI projects.
  • Drive innovation under initiative within the orthopaedics field's constraints. Identify new technologies which can bring innovation to support NPI/PPI projects and provide cost and time savings for in-process inspection and collaborate with the Continuous Improvement teams to realise these benefits.
  • Support the activities required to purchase new items of inspection equipment and this will include providing information for project budgets and the justification of the expenditure via the CAPEX process.
  • Provide support during the creation of manufacturing drawings with a sound understanding of Geometric Dimensioning and tolerancing to ASME Y14.5-2009 to provide guidance and advice to the design or production team to ensure the datums and tolerancing support the design intent of the product and critical features can be measured by the correct inspection equipment.
  • Engage suppliers about complex projects with a high degree of innovation and risk provide feedback regarding the quality of supplied parts and collaborate and share information with the Supplier Quality Team
  • Promote the sharing of knowledge about process engineering applied to orthopaedic technologies.
  • Support the company's Corrective and preventive Actions (CAPA) activities and act as a subject matter expert for the Process Engineering tasks within the assigned CAPA project and ensure that process and timeline requirements for CAPA are met by Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives.
  • Support for internal audits.

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