Talent.com
Documentation Coordinator

Documentation Coordinator

EndologixSanta Rosa, CA, US
3 days ago
Job type
  • Full-time
Job description

Documentation Coordinator

Join our Quality team at Endologix!

Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician trainingsupported by industry-leading clinical evidence. At Endologix, we're driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health.

What sets us apart is not just our technology, but our culture. At Endologix, we foster a collaborative, mission-driven environment where every team member plays a vital role in advancing patient care. We value integrity, tenacity, and innovationand we support our people with the tools, trust, and training they need to grow and continuously learn. If you're passionate about making a meaningful impact in healthcare, you'll find purpose and belonging here.

Responsibilities

What You'll Do :

  • Receives, sorts, logs, files and checks out / checks in production history records and data sheets. Maintains recent records in filing cabinets. Transfers old records to plastic containers; labels and relocates to long-term storage shelving.
  • Issues and archives engineering builds and laboratory notebooks.
  • Retrieves quality records requested during an internal and / or external audit.
  • Helps coordinate training compliance for satellite employees.
  • Processes protocols and reports, scans and uploads documents to MasterControl.
  • Supports user requests for documentation and updates satellite areas within the facility.
  • Maintains records in the document control storage room in a state of audit readiness.
  • Responsible for providing support for coordinating document change orders (DCO), coordinates review and approval.
  • Performs filing and scanning of quality system documentation.
  • Performs other duties as assigned by supervisor.

Qualifications

What You'll Bring : Education :

  • High school diploma required; Associate degree preferred.
  • Experience :

  • Experience in a pharmaceutical or medical device manufacturing environment desired.
  • Experience with electronic documentation & training system a plus.
  • Skills / Competencies :

  • Knowledge of ISO and GMP regulations desired.
  • Knowledge of documentation control requirements for medical device manufacturing to meet FDA and ISO 13485 regulations desired.
  • Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage the completion of multiple tasks / projects with company personnel.
  • Strong interpersonal skills, with the ability to communicate effectively with all levels of staff, including non-technical and technical personnel.
  • Must be quality-oriented and willing to promote quality standards.
  • How You'll Show Up :

    All In : Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of your work. Move with urgency, deliver on your promises, and lead with boldness and passion.

    Act with Integrity : Prioritize ethics and transparency in every decision. Earn trust by being honest, respectful, and dependableworking diligently to uphold the confidence of your colleagues, customers, and communities.

    Tenacious : Meet challenges head-on with resilience and resolve. Stay focused, push through obstacles, and consistently look for solutions, not excuses.

    Pioneering : Challenge the status quo and embrace innovation. Develop new ideas, test bold solutions, and pave the way for othersdriving progress through curiosity and creativity.

    What We Offer :

    At Endologix, we know that great work starts with great peopleand people do their best when they feel valued and supported. That's why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You'll be part of a team that's making a real impact on patients' lives. When you join us, you're not just taking a job, you're building a meaningful career with a team that's invested in your success.

    The compensation package includes :

  • Hourly rate of $24 / hr-$26 / hr
  • Discretionary bonus
  • Equity participation as approved by Board of Directors (4-year vesting schedule)
  • Comprehensive health, dental, and vision insurance plans
  • Generous PTO and holiday schedule
  • 401(k) retirement plan with company match
  • Plus :

  • Employee wellness initiatives and mental health support
  • Collaborative and inclusive company culture focused on impact and innovation
  • Opportunities for career growth and internal mobility
  • Our Commitment to Diversity and Inclusion :

    Endologix LLC is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

    Create a job alert for this search

    Documentation Coordinator • Santa Rosa, CA, US