PMO Team Member – Tool Validation & QMS Automation

5 years

0 Lacs

Posted:2 days ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

Job Title:

PMO Team Member– Tool Validation & QMS Automation

Job Summary:

PMO Lead

Key Responsibilities:

Tool Validation and Automation

  • Own and manage the lifecycle of tool validation projects including planning, risk assessment, requirements, testing, and documentation.
  • Develop and maintain

    validation plans

    ,

    protocols (IQ/OQ/PQ)

    , and

    summary reports

    in compliance with applicable regulatory requirements.
  • Implement

    automated validation frameworks

    for recurring validation tasks using modern scripting, CI/CD tools, or generative AI techniques.
  • Maintain a validated state of tools including updates, patches, and audit readiness.

QMS Document Automation

  • Identify opportunities to

    automate the creation, review, and management of QMS documents

    using AI tools, templates, or custom scripts.
  • Lead the evaluation and deployment of document automation tools compatible with QMS platforms (e.g., Jama, ADO, Jira, Polarion).
  • Collaborate with Quality, Engineering, and IT to align automation efforts with document control policies.

Tool Research and Productivity Improvement

  • Continuously scan and evaluate emerging tools and technologies that enhance

    engineering productivity, traceability, testing, and compliance

    .
  • Conduct

    feasibility assessments

    and

    proof-of-concepts

    (PoCs) for candidate tools, including ROI, TCO, regulatory fit, and user impact.
  • Create and maintain a tool evaluation matrix and decision logs.
  • Lead vendor engagements, pilot planning, and rollout coordination.

Cross-functional PMO Responsibilities

  • Act as the

    bridge between Quality, Engineering, and IT

    to streamline tooling decisions and validations.
  • Maintain dashboards and metrics for tool usage, compliance status, automation ROI, and productivity KPIs.
  • Facilitate project governance and stage-gate reviews for tool-related initiatives.

Required Qualifications:

  • Bachelor’s degree in engineering, Computer Science, Quality, or related discipline.
  • 5+ years of experience in regulated industries (e.g., medical devices, pharma, SaMD, life sciences).
  • Experience with digital health software, including regulated SaMD (Software as a Medical Device) and health IT platforms.
  • Solid experience with

    software tool validation

    , including CSV (Computer Software Validation) under FDA 21 CFR Part 11, ISO 13485, or GAMP 5.
  • Strong knowledge of

    QMS systems

    , documentation requirements, and modern document automation platforms.
  • Experience with

    AI/ML or low-code automation tools

    (e.g., ChatGPT, Python scripting, Power Automate, Workato).
  • Familiarity with productivity and lifecycle tools (e.g., Azure DevOps, Jama, Jira, GitHub, TestRail).
  • Excellent communication, stakeholder management, and technical documentation skills.
  • Strong experience and understanding of Product/Software Development lifecycle and Agile/DevOps methodologies.

Preferred Qualifications:

  • Experience with

    design control frameworks

    (IEC 62304, IEC 82304-1).
  • Working knowledge of

    risk management

    (ISO 14971).
  • Experience in

    DevOps toolchains

    and

    infrastructure-as-code (IaC)

    .
  • Familiarity with RFP and vendor assessment processes.

Success Metrics:

  • 20% Reduction in tool validation cycle time via automation in the first year.
  • 10% of QMS documents are generated or managed through automated workflows.
  • Tool adoption rate and user satisfaction post-deployment.
  • Audit readiness and compliance findings related to tools and documentation.
  • Visible tool tracking for validation

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