Document Control Manager

4 weeks ago


Palo Alto, California, United States Kohler Full time

Job Summary:

Kohler Ventures is seeking a highly skilled Document Control Manager to join our team. As a key member of our Quality Systems team, you will be responsible for the management of our Document Management System, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:

  • Lead administrator for the company's Document Management System, including the Learning Management System
  • Provide customer support and troubleshooting for creation and editing of documents and workflows
  • Support associate training in all aspects of the Document Management System
  • Support initial product complaint in-take and customer contact through investigation to resolution
  • Author or review and approve documentation associated with the Quality Management system
  • Support design & development and manufacturing sites in all aspects of local document management
  • Support regulatory agency inspections and notified body inspections in concert with the Kohler Ventures Management Representative
  • Lead or participate in internal audits and provide recommendations for corrective and preventive action as appropriate

Requirements:

  • 5+ years of demonstrated success as Lead administrator for a tier one Document and Learning Management System
  • QT9, Arena, or comparable medical device doc control software experience is preferred
  • Bachelor's Degree in Life Science or other related fields
  • 5+ years' experience working in a medical device company as a Lead administrator for the Document Management and Learning System
  • Experience in all aspects of medical device document content, including SOP/WI, CAPA, Complaints, Non-conformances, DHR, DMR, CAD, and Procurement
  • Experience in technical writing related to wellness devices
  • Experience in developing SOPs, work instructions and report templates and training personnel in accordance with applicable regulations
  • Working knowledge of regulations and standards set forth under FDA, ISO standards and Agile software development

Why Choose Kohler?

We empower each associate to #BecomeMoreAtKohler with a competitive total rewards package to support your health and wellbeing, access to career growth and development opportunities, a diverse and inclusive workplace, and a strong culture of innovation.

With more than 30,000 bold leaders across the globe, we're driving meaningful change in our mission to help people live gracious, healthy, and sustainable lives.

About Us:

Kohler's policy is to recruit, hire, and promote qualified applicants without regard to race, creed, religion, age, sex, sexual orientation, gender identity or expression, marital status, national origin, disability or status as a protected veteran.

If, as an individual with a disability, you need reasonable accommodation during the recruitment process, please contact . Kohler Co. is an equal opportunity/affirmative action employer.



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