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Engineering Jobs

Quality Engineer

Katalyst Healthcares & Life Sciences

  • Andover, MA
  • 8 days ago

    Highlights

    We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. Required Qualifications: Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.

    Numbers & Facts

    LocationAndover, MA

    Description

    Summary:
    We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and manufacturing/validation processes.
    Roles & Responsibilities:
    • Support quality activities related to manufacturing processes, products, and equipment.
    • Review and maintain quality documentation, SOPs, work instructions, and quality records.
    • Support CAPA, Client/deviations, root cause analysis, and corrective actions.
    • Participate in process validation, equipment qualification, and change control activities.
    • Support internal and external audits and ensure compliance with applicable regulatory requirements.
    • Work with Engineering, Manufacturing, R&D, and Quality teams to identify and resolve quality issues.
    • Ensure compliance with GMP/cGMP, FDA 21 CFR, ISO 13485, and other applicable standards.
    • Assist with continuous improvement and maintain strong documentation and data integrity practices.
    Required Qualifications:
    • Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.
    • 0-2 years of experience in Quality Engineering/Quality Assurance.
    • Experience in medical devices, pharma, biotech, or another regulated industry.
    • Knowledge of CAPA, Client, deviations, change control, validation, audits, and quality systems.
    • Strong communication, analytical, documentation, and problem-solving skills.

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