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iRhythm Technologies

Document Control Specialist - Quality Systems

Cypress, CA

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.

About this role:

iRhythm is currently seeking an experienced Document Control Specialist. The Document Control Specialist is responsible for maintaining a compliant change control process within the Global Document Control System as well as managing and implementing the process associated with the creation and revision of iRhythm’s Quality System Documents globally. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

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Specific job responsibilities include:

  • Responsible for overall coordination of controlled documents within iRhythm’s global Document Control system
  • Maintain and improve processes associated with the electronic document control system Ensures timely completion and version control of all new and revised documentation
  • Work cross functionally to ensure document change orders (packets) are executed in a timely manner.
  • Responsible for the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control procedures
  • Aids in the responses to internal and external audits as they related to the Document Control process
  • Supports user requests for documents
  • Performs self-audits of satellite controlled binders, and ensures that current revision is available at point-of-use in a timely manner
  • Maintains quality records per applicable SOPs
  • Responsible for coordinating document change orders (packets), collaboration, approval, release, and retention.
  • Other duties may be assigned as deemed necessary by management

About you:

  • Strong communication (verbal and written) and interpersonal skills
  • Attention to detail and timeliness are critical 
  • Computer Skills: software proficiency in Microsoft Office Suite is required
  • Previous MasterControl experience is highly desirable
  • Must build rapport across functional teams within the organization  
  • Bachelor’s Degree or equivalent experience  
  • Minimum of 2 years of experience in Document Management System 
  • Thorough understanding of Medical Device regulations and FDA regulatory processes for Document Control and/or Document Management required. Knowledge of ISO3485 is a plus  
  • Must operate through collaboration and transparency  
  • Experience in cGMP/GDP/GCP environments and FDA regulated industries is preferred

What’s in it for you:

This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!

iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

#LI-JR1

Job ID: 3787352
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • FSA
    • HSA
    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
  • Parental Benefits

    • Non-Birth Parent or Paternity Leave
    • Birth Parent or Maternity Leave
  • Work Flexibility

    • Remote Work Opportunities
  • Office Life and Perks

    • Company Outings
    • Commuter Benefits Program
    • Casual Dress
    • Happy Hours
    • Snacks
    • Some Meals Provided
  • Vacation and Time Off

    • Paid Holidays
    • Paid Vacation
  • Financial and Retirement

    • Performance Bonus
    • Stock Purchase Program
    • Company Equity
    • 401(K) With Company Matching
  • Professional Development

    • Promote From Within

Company Videos

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