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QMS Coordinator
QMS CoordinatorActalent • Jacksonville, FL, US
QMS Coordinator

QMS Coordinator

Actalent • Jacksonville, FL, US
Hace 3 días
Tipo de contrato
  • Indefinido
Descripción del trabajo

QMS Coordinator

Join our team as a QMS Coordinator, where you will play a vital role in the administrative coordination of regulatory and quality tasks, focusing primarily on complaint processing. You will assist in implementing and maintaining quality management system processes and support the RA / QMS department in various initiatives. This role involves managing the complaint lifecycle, maintaining data integrity, and supporting audit activities.

Responsibilities :

  • Receive, log, and process customer complaints in accordance with company procedures and regulatory requirements.
  • Coordinate investigations, track status, and ensure timely closure of complaints.
  • Support the intake and administrative handling of complaints, including gathering relevant information from internal and external sources.
  • Assist in reporting and processing complaints in SAP and other designated systems.
  • Ensure all complaint records are complete, accurate, and compliant with internal procedures.
  • Update tracking systems and maintain documentation throughout the complaint lifecycle.
  • Coordinate the return of products related to complaints with internal and external parties.
  • Track and document product movement as part of the complaint process.
  • Serve as a backup in Document Management, including processing and tracking controlled documents.
  • Review and assist with drafting controlled document procedures related to complaint handling.
  • Compile complaint data and generate reports and summaries for internal quality reviews and management reporting.
  • Serve as backup coordinator for calibration-related procedures.
  • Assist in creating and maintaining material master data in applicable systems.
  • Assist in the collection, entry, and analysis of quality data as needed to support regulatory and quality functions.
  • Contribute to ongoing Quality Management System (QMS) initiatives and compliance efforts.
  • Collaborate with cross-functional teams to collect information and resolve complaint-related issues.
  • Prepare complaint files and documentation for internal audits or external regulatory inspections.
  • Maintain audit-ready complaint documentation at all times.

Essential Skills :

  • 2-year degree plus 2 years of administrative experience, or 4 years of administrative experience.
  • Proficient user of Microsoft Office applications, with intermediate knowledge of MS Excel.
  • Must be proficient with Microsoft Outlook.
  • Excel functions : Pivot Tables, Sorting Data, Searching Data, Organizing specific data, creating / amending excel sheets per request of product / sales rep.
  • Additional Skills & Qualifications :

  • SAP experience preferred.
  • MDR or Complaint investigating experience in Medical Device is highly desirable.
  • ISO experience / exposure / internship is highly desirable.
  • Work Environment :

    This role offers a work-from-home arrangement with some in-office presence as requested. You will work in a cubicle-style office alongside the regulatory and QA team, supporting the growth of a company that supplies life-changing medical devices impacting the lives of patients in need.

    Job Type & Location :

    This is a Permanent position based out of JACKSONVILLE, Florida.

    Pay and Benefits :

    The pay range for this position is $44000.00 - $46000.00 / yr. Full benefits 401K Hybrid working flexibility.

    Workplace Type :

    This is a fully remote position.

    Application Deadline :

    This position is anticipated to close on Nov 8, 2025.

    About Actalent :

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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    Qms Coordinator • Jacksonville, FL, US

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