Quality Investigation Coordinator

Intellectt INC

  • Boston, MA
  • 5 days ago

    Highlights

    The ideal candidate will have experience initiating investigations, coordinating with cross-functional teams, gathering information from the manufacturing floor, and preparing clear, accurate investigation reports. The candidate should be a self-starter with strong technical writing skills, an engineering background, and the ability to follow up with stakeholders to ensure timely completion of quality events.

    Numbers & Facts

    LocationBoston, MA

    Description

    Job Title: QA Investigator / Quality Investigation Coordinator
    Location:Boston, Massachusetts
    Rate: $35/hr
    Vendor: Oxford

    Job Summary
    We are seeking a proactive and detail-oriented QA Investigator to support quality investigations, deviation management, and event documentation within a manufacturing or engineering environment. The ideal candidate will have experience initiating investigations, coordinating with cross-functional teams, gathering information from the manufacturing floor, and preparing clear, accurate investigation reports. This role is primarily focused on investigation initiation, documentation, follow-ups, and coordination rather than advanced root cause analysis. The candidate should be a self-starter with strong technical writing skills, an engineering background, and the ability to follow up with stakeholders to ensure timely completion of quality events.

    Key Responsibilities

    • Initiate and coordinate quality investigations related to manufacturing and engineering events.
    • Support the documentation and management of deviations, nonconformances, and other quality events.
    • Gather relevant information by interacting with manufacturing personnel, engineering teams, and other cross-functional stakeholders.
    • Visit the manufacturing floor to collect facts, clarify event details, and follow up on outstanding investigation activities.
    • Prepare clear, accurate, and well-organized investigation reports and event documentation.
    • Perform preliminary or Tier 1 root cause analysis based on available information and established procedures.
    • Coordinate investigation activities and track action items through completion.
    • Follow up with relevant stakeholders to obtain missing information, supporting documents, and investigation updates.
    • Ensure investigation records are complete, accurate, and compliant with applicable quality procedures.
    • Assist in identifying potential causes of quality events and documenting findings.
    • Support CAPA-related activities, as applicable, including action tracking and documentation.
    • Maintain investigation records and ensure timely completion of assigned quality events.
    • Collaborate with Quality Assurance, Manufacturing, Engineering, and Validation teams to support effective investigation closure.
    • Escalate overdue actions, documentation gaps, and unresolved issues to the appropriate team members.

    Required Qualifications

    • 2 4 years of experience in Quality Assurance, Quality Investigations, Manufacturing Quality, Engineering, or a related field.
    • Engineering background or relevant technical experience in a manufacturing environment.
    • Experience with deviation management, quality events, nonconformances, or investigation documentation.
    • Strong technical writing and report preparation skills.
    • Basic understanding of root cause analysis and problem-solving methodologies.
    • Ability to collect information, ask relevant questions, and document investigation findings.
    • Strong organizational, communication, and follow-up skills.
    • Ability to work independently and proactively drive investigation activities to completion.
    • Willingness to work onsite and interact directly with manufacturing floor personnel.
    • Strong attention to detail and the ability to manage multiple investigation records simultaneously.

    Recruiter Contact:
    Name: Pavani Samboju
    Email:

    pavani.samboju@intellectt.com


    Phone: 732 993 4972
    INTELLECTT INC

    Equal Employment Opportunity:
    Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
    Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
    Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
    Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.
    Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

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