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Quality System Documentation Specialist | Contract | Irvine, CA (onsite)

Trinus
Irvine, CA Full Time
POSTED ON 2/14/2025
AVAILABLE BEFORE 5/13/2025

Job Description

Job Description

Summary : The Documentation Specialist is responsible for ensuring the proper documentation is in place to meet regulatory requirements and maintain compliance with quality systems.

Key Responsibilities :

  • Review and evaluate change packages against governing procedures, collaborating with various departments to finalize and release the documentation.
  • Incorporate approved changes into relevant documentation, including data entry and verification of correct implementation.
  • Participate in special projects, meeting deadlines and deliverables as assigned.
  • Provide feedback on proposed changes from initiators and evaluating their impact; Also, Perform other duties as assigned by leadership.

Independence & Decision-Making :

  • Work independently with minimal supervision, making informed decisions based on guidelines and procedures.
  • Evaluate potential risks and recommend appropriate courses of action after considering various alternatives.
  • Offer guidance to lower-level personnel when necessary, ensuring tasks align with overall objectives.
  • Demonstrate sound judgment in problem-solving and decision-making, ensuring compliance with standards.
  • Skills & Qualifications :

  • Proficient in Microsoft Office Suite and project management software.
  • Strong communication skills (both written and verbal) and interpersonal abilities.
  • Critical thinking and problem-solving expertise.
  • Familiarity with medical device documentation, regulatory guidelines, and internal procedures.
  • Ability to handle confidential information with discretion.
  • Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
  • Knowledge of safety, health, and environmental (EHS) requirements and compliance.
  • Education & Experience :

  • Bachelor's degree in a related field.
  • 2-4 years of relevant experience in documentation and quality control.
  • Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE / MBE / SBE / SDB firm accredited by WBENC, NMSDC, and SBA.

    Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.

    At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.

    To learn more about us, please visit our website www.trinus.com

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