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    Quality Engineer - Plymouth, United Kingdom - Adecco

    Adecco
    Adecco Plymouth, United Kingdom

    2 weeks ago

    Adecco background
    Full time
    Description

    Job Title: Quality Engineer

    Industry: Medical Device Manufacturing

    Location: Plymouth

    Position Type: Permanent

    About The Company

    Be part of an innovative team at a UK-based organization specializing in advanced wound care and wound closure products. The company is committed to developing and manufacturing cutting-edge solutions that improve patient care. With a wealth of resources and specialized expertise, they offer a unique opportunity to contribute to every stage of product design, development, and production.

    Job Description

    Overview

    Reporting to the Quality Manager, you will oversee technical documentation, project management, and coordination with other departments.

    This role involves maintaining compliance with relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC.

    Key Responsibilities

    • Deputy to the QM
    • Maintain and enhance quality compliance
    • Identify, manage, and implement continuous improvement initiatives
    • Evaluate product & process risks following Medical Device Risk Management requirements
    • Support New Product Introductions
    • Handle & investigate Customer complaints
    • Resolve non-conformances promptly and implement effective corrective action
    • Prevent potential areas of non-conformance
    • Reduce QMS non-conformances and Customer Complaints
    • Implement product, process, and QMS changes in a timely manner
    • Avoid product recalls
    • Adhere to approved procedures, QMS, GxP & Regulatory requirements
    • Generate and maintain documentation to support a compliant QMS
    • Conduct internal and process audits as necessary
    • Supervise goods-in inspection
    • Participate in quality issue investigations and identify effective CAPA
    • Provide quality support to manufacturing
    • Review, update, and maintain Quality procedures and instructions
    • Support training and change control processes
    • Provide quality support for manufacturing projects
    • Communicate effectively with various departments and levels

    Qualifications

    • BS Degree in Engineering or Science field / 5 years Quality Assurance experience within manufacturing QE
    • Experience in medical device industry and ISO13485/FDA QSR knowledge
    • Strong attention to detail and knowledge of quality techniques
    • Proficiency in validation, data integrity, technical drawing, and more
    • Familiarity with GMP, GLP, and Quality Systems
    • Organized with good communication and problem-solving skills
    • Ability to work autonomously and in a team environment

    Salary & Benefits

    Up to £35,000 per annum

    • Annual incentive bonus
    • Life Cover
    • Pension contribution up to 6%
    • Dental Insurance
    • Employee share scheme

    How to Apply

    Interested candidates can submit their CV below, or send it to the provided email address with "Quality Engineer" in the subject line.

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