Design Quality Engineer

Location: Blackpool, Lancashire Salary: £35.00 - £40.00 per hour
Sector: Medical Devices Specialism:
Type: Contract Contact: Matt Henocq

Design Quality Engineer

Job purpose:
Reporting to the Design Quality Engineering Manager the Senior Design Quality Engineer shall lead product development efforts for my client and associated areas of activity.
The job holder will lead product development activities from a Technical Quality perspective by preparing appropriate Risk Management plans, reviewing Design Control plans and overseeing qualification & validation process with internal manufacturing sites and/or external suppliers.

Principal Accountabilities:

  • Risk Management oversight and review during DHF development and product life cycle phases. Driving the creation of an appropriate Risk Management Plan at the product concept phase and maintaining this plan to all phases.
  • Deliver compliant transfers of Design History Files where required, ensuring transferred systems are understood and integrated into the Quality System.
  • Supporting risk assessment activities: Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
  • Support the product post market surveillance process from a technical Quality perspective.
  • Review & report on analysis of field inquiry reports and support or lead in product Health Hazard Evaluations.
  • Ensure effective problem analysis/complaint investigation (CAPA) as required and define through negotiation effective corrective actions.
  • Develop effective Process Verification Strategies working with all product development cycle stakeholders.
  • Provide reliability objectives & assessment plans for Product Development and sustaining team.
  • Liaise with R&D to ensure CTQ (Critical To Quality) specifications are agreed and documented for all NPD.
  • Lead Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.
  • Lead QA input in Design for Manufacture activities.
  • Produce quality process specifications as required during the development and implementation of new products. Approve design specifications (e.g. drawings, protocols) as defined for own scope of responsibility.
  • Partner with affiliated disciplines (I.e. R&D, Regulatory Affairs, Clinical Affairs) work cross-functionally to ensure adequate design inputs are included in product development or change projects.
  • Document and maintain in good order all relevant Quality documents.
  • Working with relevant business stakeholders, support and lead in the Non-Conformance (NC),Corrective And Preventative Action (CAPA) investigations and general problem solving for both design and process.
  • Provide statistical support for DOE (Design of Experiments), sampling plans, capability assessments, rationale development & hypothesis tests as required.
  • Compile and execute validation protocols for new product/processes. Assist in resolving all quality issues, allowing transfer of manufacturing processes to Operations.
  • Ensure consistency with other team QE's, site Quality Systems and corporate Quality Systems.
  • Ensure compliance with all Documented Quality system, as per FDA QSR's and ISO13485/9001 requirements etc. during day to day activities.
  • Assist the Quality Systems Manager and Compliance Manager to manage the regulatory compliance program to include FDA and BSI.

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