Technical Documentation Specialist I

4 weeks ago

Trumbull, Connecticut, United States Cooper Companies Full time
About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. We offer a wide range of products and services for use by women's healthcare clinicians, including testing and treatment options.

Responsibilities

The Document Control and Training Specialist will support the accurate and efficient management of controlled documents and the timely execution of training programs. Key responsibilities include:

  • Supporting the day-to-day Document Change Management process for Trumbull-related documents
  • Receiving and reviewing document change requests, processing them in the Document Control System
  • Assigning document approvals as per the approval matrix and routing documents in the system
  • Assisting with document formatting, template creation, and management, as well as document and record distribution and archival
  • Ensuring printed documents are controlled and organized according to established procedures
  • Reviewing and editing formatting of documents to conform to current templates
  • Assisting in managing the Periodic Review program to ensure controlled documents are periodically reviewed for relevance and accuracy
  • Helping to maintain and enhance the records management systems, including storage, retrieval, and retention
  • Managing the Trumbull site Training System for all Trumbull employees
  • Ensuring that Training Matrixes are up to date as per current procedures for all Trumbull site positions
  • Ensuring training requirements are met prior to implementation of site policies and procedures for employees
  • Monitoring and supporting the creation and revision of Training job roles, curriculum, and training requirements
  • Responsible for monitoring and reconciliation of completed training
  • Managing standard operational training programs and evaluating their effectiveness
  • Assisting in tracking and trending of Document Control and Training metrics for the Trumbull site

This position may require 5-10% domestic and international travel.

Qualifications

The ideal candidate will have:

  • A Bachelor's degree in a health, engineering, or science field
  • Minimum 2 years of experience working in the medical device or healthcare industry
  • Minimum 1 year of experience working with controlled document and training systems
  • Experience working with electronic Quality Management Systems
  • Knowledge of relevant quality standards and regulations, including ISO 13485 and 21 CFR 820
  • Experience administering document control and training systems
  • Able to handle multiple tasks with extreme attention to detail
  • Proficiency in computer skills, including Microsoft Word, Excel, and PowerPoint
  • Ability to work with electronic Quality Management System software, using document control and training modules
  • Ability to work with cross-functional teams to drive continuous improvement
  • Demonstrated strong interpersonal, communication, and coaching skills

As an employee of CooperSurgical, you'll receive an outstanding total compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits.

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