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Quality Engineer

  • Massachusetts, Raynham

  • 04/29/2026

  • Contract

  • Active

Job Description:

  • Job Summary
    We are seeking a Quality Engineer to support laboratory quality and validation activities within a regulated medical device environment. This role is part of a global compliance team and focuses on ensuring adherence to quality standards through audit support, CAPA management, and nonconformance investigations. The ideal candidate will collaborate with cross-functional teams and contribute to maintaining high-quality performance and regulatory compliance.

    Key Responsibilities
    • Support execution of quality systems for assigned laboratory teams, including tracking metrics such as nonconformance (NC), CAPA, and audit timelines
    • Manage and support nonconformances, CAPA activities, and audit observations, ensuring timely resolution
    • Review and support validation documentation including test methods, software validation, and instrument validation
    • Review and approve calibration and maintenance records with oversight
    • Support software validation activities for laboratory systems and tools
    • Participate in Agile ceremonies such as scrum meetings and collaborate with global teams
    • Act as a point of contact for compliance-related issues
    • Compile and track nonconformance records and related quality documentation
    • Work closely with Test Engineers, R&D, and Quality teams to ensure compliance and quality deliverables

    Required Qualifications
    • Bachelor’s degree in Engineering, Science, IT, or a related field
    • Minimum 2 years of experience in a regulated industry
    • Experience working with quality systems and processes
    • Experience handling nonconformances (NCs) and CAPA processes
    • Experience with software validation and laboratory environments
    • Strong technical writing, analytical, and problem-solving skills
    • Ability to manage multiple tasks and priorities effectively
    • Strong attention to detail and documentation skills

    Preferred Qualifications
    • Experience in a medical device laboratory environment
    • Knowledge of regulatory guidelines and compliance standards
    • Experience with ETQ or similar quality management systems
    • Experience in design or product/process quality engineering
    • Familiarity with laboratory testing environments and validation processes

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