Documentation Control Specialist

3 weeks ago

Trumbull, Connecticut, United States Cooper Companies Full time
About This Role

We are seeking a highly skilled Documentation Control Specialist to join our team at CooperSurgical.

Job Summary

This role will support the accurate and efficient management of both paper and electronic controlled documents within our Quality Management System (QMS) and ensure timely execution and management of training system.

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

Key Responsibilities
  • Support the day-to-day Document Change Management process for Trumbull related documents.
  • Receive and review document change requests (for new documents and changes to existing ones), processed them in Document Control System.
  • Assign document approvals as per approval matrix. Route documents changes in the system.
  • Assistance on document formatting, template creation and management, document, and record distribution, and archival when applicable.
  • Ensure printed documents are controlled and organized according to established procedures.
  • Review / Edit formatting of documents to conform to current templates.
  • Assist in managing the Periodic Review program to ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in the applicable procedures and adhere to the applicable regulatory standards.
  • Help to maintain and enhance the records management systems including storage, retrieval, and retention.
  • Manage Trumbull site Training System, for all Trumbull employees.
  • Ensure that Training Matrixes are up to date as per current procedures, for all Trumbull site positions.
  • Ensure training requirements are met prior to implementation of site policies and procedures for employees.
  • Monitor and support the creation and revision to Training job roles, curriculum, and training requirements.
  • Responsible for monitoring and reconciliation of completed training.
  • Manage standard operational training programs and evaluate their effectiveness.
  • Assist in tracking and trend of Document Control and Training metrics for the Trumbull site.
Requirements
  • Bachelor's degree in a health, Engineering or Science field required; Advanced degree preferred.
  • Minimum 2 years working in Medical Device or healthcare industry companies, or similar regulated industries.
  • Minimum of 1 year of experience working with Controlled Document and Training System
  • Experience working with electronic Quality Management System
  • Knowledge of relevant quality standards and regulations, including ISO 13485, 21 CFR 820, MDSAP
  • Experience administering Document Control and Training System
  • 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 team to drive continues improvement.
  • Demonstrated strong interpersonal, communication, and coaching skills are essential.
Compensation Package

The estimated salary range for this role is $80,000 - $110,000 per year, depending on experience.

You'll receive an outstanding total compensation plan, including a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

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