Job Title: Quality Assurance Engineer - Electrical
Reports To: Quality Manager
Group/Division: Speciality Diagnostics Group/Anatomical Pathology Business Unit
Career Band: 6
Job Track: Professional
Position Location: Runcorn, UK
This position supports the manufacture and release of electromechanical software driven Instruments and their associated accessories, in order to meet the needs of our customers and business objectives. This role ensures that quality defects (e.g. customer complaint) or nonconformities are investigated to root cause, corrective actions identified and effectively implemented. Work activities are performed in compliance with EN ISO13485, FDA QSR Part 820 and all other relevant global Quality Management System requirements.
Investigate customer complaints using effective problem solving/root cause analysis tools & methodologies.
Set up and lead multifunctional teams in the handling of customer complaint investigations and CAPA determination.
Document final complaint investigations and outcomes.
Perform and/or coordinate with other staff members (e.g. QA Technicians) in generating new and/or reviewing existing inspection & test data/DHR.
Work with Supplier Quality Engineering, Sourcing and/or directly with the supplier, in the investigation of purchased component quality issues. This includes confirming the non-conformance, capturing relevant inspection & test data, and working with the supplier to determine root cause / CAPA’s.
Interface with QA Specialist’s to ensure complaint handling and CAPA system requirements are met.
Support the investigation of in-process or final acceptance failures (non-conformances) during the instrument build, working with Manufacturing, Production Engineering, Engineering Technical Support (ETS), and R&D as required.
Capture, report and present relevant quality metrics and data.
Lead/participate in Practical Process Improvement – Lean Enterprise (PPI-LE) activities to drive continuous product & process improvements.
Manage the calibration of inspection, measuring and test equipment.
Contribute to quality requirements in the evaluation of new or alternatively sourced components, and monitoring any ‘shop floor’ trial activity.
Support and participate in any external or internal Quality System Audits; acting as a subject matter expert (SME) as required.
Contribute to quality requirements and support the effective design transfer of new/updated products from R&D/Engineering into Manufacturing.
Perform tasks to support the quality system and quality policy as directed by QA/RA management.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action Employer
Higher National Diploma (or equivalent) in an Electrical Engineering discipline.
Grade C or above in GCSE (or equivalent) Maths & English.
Experience of working with Medical Device/IVD regulated products, with knowledge of ISO13485 / FDA QSR Part 820 requirements
Knowledge of quality investigation and improvement tools, (8D, cause & effect, FMEA, 5Whys etc.)
Knowledge of statistical techniques (Gage R&R, Acceptance Sampling, Process Capability, Statistical Process Control),
Basic knowledge of PPI lean methods (5S, Lean Six Sigma, Kaizen)
Excellent interpersonal and communication skills both written & oral
Project management experience.
Ability to work in a timeline driven environment and under own initiative.
Excellent IT skills
Up to 5% travel (UK, European & International)
Bachelor of Engineering honors degree (or equivalent) in an Electrical Engineering discipline.
Experience & recognised training in auditing, risk management, design transfer and design verification/validation.
Experience of performing internal audits / supporting external audits