Quality Engineer (Contract)

139095
  • Competitive
  • London, United Kingdom
  • Contract

Job Title: Quality Engineer - Medical Device (Contract - 12 Months)

Company Overview:

Join a dynamic and innovative Medical Device company dedicated to advancing healthcare through their hardware device. Our client is seeking a highly skilled Quality Engineer to join their team on a 12-month contract basis. If you have a passion for ensuring the highest standards in medical device quality and possess a minimum of 5 years of experience, we invite you to apply for this exciting opportunity.

Position: Quality Engineer - Medical Device

Location: Hybrid (On-site and Remote)

Duration: 12 Months Contract

Responsibilities:

  1. Quality Assurance:

    • Collaborate with cross-functional teams to ensure the quality and regulatory compliance of our medical device products.
    • Conduct risk assessments and implement effective risk mitigation strategies.
  2. Regulatory Compliance:

    • Ensure adherence to relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
    • Support regulatory submissions and communicate with regulatory agencies as needed.
  3. Supplier Quality Management:

    • Work closely with suppliers to establish and maintain quality standards for incoming components.
    • Conduct supplier audits and assessments to ensure compliance with quality requirements.
  4. Quality Systems Management:

    • Manage and improve quality systems, including CAPA (Corrective and Preventive Action) and non-conformance processes.
    • Drive continuous improvement initiatives to enhance overall product quality.
  5. Product Development Support:

    • Collaborate with R&D teams to ensure that quality is built into product development processes.
    • Participate in design reviews, validation activities, and design transfer processes.
  6. Documentation and Reporting:

    • Maintain accurate and up-to-date documentation related to quality processes and activities.
    • Prepare and present quality reports to internal stakeholders.

Qualifications:

  1. Minimum of 5 years of experience in a Quality Engineer role within the medical device / MedTech industry.
  2. Strong knowledge of medical device quality standards, including ISO 13485 and FDA regulations.
  3. Experience in supplier quality management and conducting supplier audits.
  4. Familiarity with CAPA processes, risk management, and validation activities.
  5. Excellent communication and interpersonal skills to work effectively with cross-functional teams.
  6. Bachelor's degree in Engineering or related field.

How to Apply:

If you are a results-driven Quality Engineer with a proven track record in the medical device industry and are excited about contributing to the next generation of healthcare solutions, please contact ryan.prouse@peoplewithchemistry.com


 
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