Technical Documentation Specialist I

2 months ago

Trumbull, United States Cooper Companies Full time
Job Description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Responsibilities

CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Document Control and Training Specialist will support the accurate and efficient management of both paper and electronic controlled documents retained within Document Control for Quality Management System (QMS) and the timely execution and management of training system.

Essential Functions & Accountabilities:
  • 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.
Travel:

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

#LI-DD1

Qualifications
  • 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.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer 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. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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