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Quality Engineer

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Intro Personnel

Job Overview

Published
February 19, 2024
Location
Stoke-on-Trent, United Kingdom
Category
Job Type
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Description

QUALITY ENGINEER
STOKE ON TRENT
PERMANENT FULL TIME HOURS

UP TO £42K DOE

THE ROLE

  • Design and create comprehensive process protocols, control plans and gap assessments for new and existing products, equipment, systems and processes
  • Conduct and review validation tests and production outputs
  • Present data on trends, pareto and information relating to quality KPI targets
  • Support in the maintenance and improvement of the company QMS in compliance with policies, procedures and standards including ISO 9001, ISO13485, ISO15378 and ISO17025
  • Generation of detailed process quality documentation, including SOP’s, reports and risk assessments, ensuring all records are maintained and organised
  • Collaborate with cross-functional teams to ensure production activities adhere to regulatory requirements and industry best practices
  • Champion internal system audits to identify improvements and completion of actions
  • Oversee equipment calibration and validation, ensuring accurate and reliable measurements and adherence to calibration schedules
  • Continuously review and improve quality processes, methodologies, and documentation to enhance efficiency, accuracy, and compliance
  • Provide training and guidance to personnel involved in quality processes
  • Promote awareness of visual management quality principles throughout the business
  • Conduct risk assessments for products and processes to identify potential hazards
  • Generate, monitor, and maintain the validation status of products and processes throughout their lifecycle, conducting periodic revalidation of design history files as required
  • Execution of validation processes IQ/OP/PQ (data collation and reports)

WHAT WE ARE LOOKING FOR

  • Bachelor's degree in Engineering (e.g. Mechanical, Electrical, Biomedical) or related field
  • Proven experience in any relevant regulated manufacturing industry
  • A strong understanding of lean manufacturing principles and methodologies
  • Knowledge of QMS and familiarity with industry regulations and standards (e.g., ISO 9001, ISO 13485, FDA 21 CFR Part 820, ISO 15378, GMP)
  • Proficiency in data analysis tools, statistical analysis, and validation software
  • Excellent communication skills
  • Strong problem-solving skills, and a proactive approach to resolving issues
  • Experience of various quality tools, risk management tools and methodologies (e.g., 8D, 5 Whys, FMEA, SPC and auditing) is desirable

HOW TO APPLY

For more information on the Quality Engineer role, please contact Emma Harvey or Rob Hulse at Intro Personnel on 01782 413307 or send your current CV to [email protected]

Due to the expected high number of applicants for the Quality Engineer role, we regret that it may not be possible to respond to all unsuccessful applications.

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