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    Quality Engineer, Design Assurance - Woburn, United States - TalentBurst, Inc.

    TalentBurst, Inc.
    TalentBurst, Inc. Woburn, United States

    1 week ago

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    Contract
    Description
    Title: Quality Engineer, Design Assurance
    Location: Woburn, MA
    Duration: 12+ Months

    Job Summary:
    We are seeking a skilled Design Assurance Engineer or Systems Engineer to join our team as a contractor for a 9-12 month term Reporting to the Director of QA/RA, the Quality Engineer, Design Assurance will establish and organize 21CFR820.30 compliant Design History Files and IVDR Class A Technical Documentation for existing Covaris systems. The ideal candidate will be a self-motivated professional with a strong background in engineering and a commitment to excellence This position will require candidate to be on site at least 3 days a week. The contractor operates in support of ISO 13485 certification and IVDR remediation.

    Responsibilities include:
    • Actively support product development initiatives with Design Assurance services including authoring documentation.
    • Support Product Development with quality documentation as needed.
    • Escalate potential issues that could impact compliance.
    • Establish technical documentation in support of IVDR Class A systems.
    • Establish System Level Design History Files
    • Identify and fill gaps in historical records.
    • Perform design verification and validation activities as needed.
    • Establish system level risk management files.
    • Perform other duties as assigned.

    Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
    • Conduct investigations of identified problems with existing products in the field and production. Use Complaints, NCMR, CAPA, and DCO processes to modify product design or manufacturing procedures as required.
    • Administer and improve quality processes, with a focus on Lean process management.
    • Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.

    Non-Essential Responsibilities: The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor.

    Qualifications:
    • Bachelor's degree (minimum) in an engineering, technical or scientific discipline or equivalent.
    • Pragmatic, entrepreneurial personality and strong self-starter. Continually strives to improve.
    • A minimum of 5+ years of working experience in Design Assurance or Systems Engineering.
    • Excellent technical writing skills
    • Understand design controls, change controls, phase gated product development processes.
    • Demonstrated track record with 21 CFR 820.30, ISO 13485, the IVDR (Class A) and ISO
    • Demonstrated track record implementing risk management files.
    • Able to create multi-source reports, trends, and interpret data with minimal oversight.
    • Communicates effectively both verbally and in writing
    • Acts decisively with Integrity and Kindness.

    Note: The candidate must be a contractor and possess flexibility in their schedule to accommodate the standardized 40-hour workweek at the Woburn, MA corporate office.

    #TB_EN
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