• Quality Engineer

    Astrix Technology (Devens, MA)


    Quality Engineer

     

    Engineering

    Devens, MA, US

    + Added - 27/10/2025

     

    Apply for Job

     

    Pay Rate Low: 40.00 | Pay Rate High: 40.00

     

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

     

    The Quality Engineer will apply Quality Engineering principles, tools, and techniques to develop and optimize systems and processes aligned with company strategy and regulatory requirements. This role plays a key part in ensuring compliance, maintaining quality standards, and supporting audits and validation programs.

     

    + **Location: Devens, MA**

    + **Contract: 6-month assignment with potential for extension or permanent conversion**

    + **Pay: 40/hr.**

    Key Responsibilities

    + Apply quality engineering methodologies to support process improvement, product quality, and compliance initiatives.

    + Support customer, regulatory, and internal audits; prepare required documentation and responses.

    + Conduct root cause analyses and risk assessments to identify and implement effective corrective and preventive actions.

    + Lead, coordinate, and maintain validation, calibration, and environmental monitoring programs across departments.

    + Perform internal and supplier audits to ensure compliance with ISO and FDA Quality System Regulations.

    + Collect, analyze, and interpret data for trend reports, metrics, quality reviews, and complaints.

    + Maintain and update the Approved Supplier Index (ASI) and review/approve QA procedures and reports.

    + Support maintenance and continuous improvement of SOPs and the Quality Management System (QMS).

    + Perform other duties as assigned by the QA Manager.

    Qualifications

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

    + CQE/CQA certification preferred.

    + 3–5 years of relevant experience in quality assurance, quality systems, or quality engineering.

    + Experience with deviation and complaint investigations, root cause analysis, and technical writing.

    + Proficiency with Microsoft Office Suite (Word, Excel, Access).

    + Strong attention to detail, organizational skills, and ability to manage multiple priorities independently.

    + Experience conducting and supporting audits required.

    + Excellent written and verbal communication skills and ability to interface effectively across departments and organizational levels.

    **_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**_

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    INDBH

    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.