Job Title: QA Specialist - Design Quality & Compliance
Reports To: Quality Manager
Group/Division: Specialty Diagnostics Group/Anatomical Pathology Division
Career Band: 6
Job Track: Professional
Position Location: Runcorn, UK
Duration: 12 months FTC
This position supports the design, manufacture and installation of new, transferred and modified products, ensuring that the resulting finished products meet all required safety, quality, reliability and regulatory standards by a process of robust design control that includes verification, validation and risk management activities. The role is based in Runcorn but where required supports design projects across the Anatomical Pathology Division including OEM, contract and CMC manufacture.
- Working with Engineering/R&D/Product Management and external OEM suppliers, develop design verification and validation (V&V) strategies to support high quality, compliant and best speed-to-market product launches.
- Review and approve claim support data and V&V protocols/reports.
- Review and approve user requirements/product specifications ensuring input from Marketing/Product Management
- Provide independent assessment and advice during design review meetings.
- Provide expertise as a subject matter expert (SME) for Design Control as per ISO13485, FDA QSR Part 820 and other international regulatory requirements; ensuring that projects are run and product design is in compliance.
- Provide expertise as a SME for Risk Management as per ISO14971 and other international regulatory requirements; ensuring that product design is in compliance.
- Provide expertise as SME for global certification of electro-mechanical products including CB reports, CSA etc.
- Support external audits of the design control and New Product Development systems.
- Coordinate with Engineering/R&D team members to ensure that electrical safety/EMC testing is performed as required to IEC 61010
- Review and approve design transfer plans and activities to ensure effective design transfer e.g. from Engineering/R&D to manufacturing & Service.
- Participate in new product post launch support teams and prepare post market review data/metrics for management/stage gate review.
- Support the preparation of CE Technical Files to demonstrate compliance with In-vitro Diagnostic Device, Medical Device, Low Voltage & Machinery Directives.
- Evaluate and approve proposed product design changes (member of ‘Change Review Board’) and give direction on testing/verification/validation requirements needed for change approval.
- Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
- A Bachelor’s Degree (or equivalent) in an Electrical/Mechanical Engineering discipline preferred, or a Scientific discipline considered
- Experience of working within R&D/Engineering design teams and/or QA/RA function
- Experience of working with Medical Device/IVD regulated Instrumentation
- Experience of product design & development for global markets
- Knowledge of ISO13485 / FDA QSR Part 820 Design Control requirements
- Excellent interpersonal skills
- Ability to work in a timeline driven environment
- Excellent communication skills both written & oral
- Excellent problem solving and influencing skills
- Up to approx. 20% travel (UK, European & International)