• Quality Engineer

    Astrix Technology (Devens, MA)


    Quality Engineer

     

    Engineering

    Devens, MA, US

    Pay Rate Low: 40.00 | Pay Rate High: 40.00

     

    + Added - 28/10/2025

     

    Apply for Job

     

    _Our Client, a Fortune 500 leader, is hiring for a Quality Engineer I. Be a part of a team setting science in motion across the biopharma, healthcare and advanced technologies industries. Are you ready to make a global impact? Join us now!_

     

    **Job Title:** Quality Engineer I

    **Location:** Devens, MA

    **Contract duration:** 1 year (possibility of extension)

    **Schedule:** 1 st shift -8:30am - 4:30pm

    **Pay rate:** $40/hr.

    Responsibilities

    + Apply Quality Engineering principles, tools, and techniques to develop and optimize systems and processes aligned with company strategy and regulatory requirements.

    + Provide support for customer, regulatory, and internal audits.

    + Utilize root cause analysis and risk assessment tools to conduct investigations and determine appropriate corrective and preventive actions (CAPA).

    + Lead, coordinate, and maintain:

    + Validations across all departments

    + Calibration Program

    + Environmental Monitoring Program

    + Conduct internal and supplier audits to ensure compliance with ISO and FDA Quality System Regulation (QSR) standards.

    + Collect, review, and interpret data for trend reports, metrics, quality system reviews, and complaint handling.

    + Maintain and update the Approved Supplier Index as required.

    + Review and approve quality assurance procedures, reports, and SOPs.

    + Support the ongoing maintenance of the Quality Management System (QMS) under the direction of the QA Manager.

    + Perform other duties as assigned.

    Qualifications

    + Bachelor’s degree in a natural or life science discipline (e.g., Chemistry, Biology, Microbiology, Cell Culture) or an equivalent combination of education, certification, and experience.

    + CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification preferred.

    + 3–5 years of relevant experience in a quality, regulatory, or laboratory environment.

    + Strong knowledge of ISO and FDA Quality System Regulations (QSR).

    + Proficiency in MS Office applications (Word, Excel, Access).

    + Demonstrated experience in deviation and complaint investigations, including use of root cause analysis tools and technical writing.

    + Detail-oriented with strong organizational, time management, and multitasking abilities.

     

    _Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_

    \#INDBH

    \#LI- DNP

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.