Document Control Specialist- Trumbull, CT

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 Trubull, CT, produces and markets a wide array of products and services for use by women's health clinicians. More information can be found at www.coopersurgical.com.

The Document Control Specialist will be responsible for the maintenance and management of controlled documents and records for CooperSurgical as well as provide administrative support to the quality assurance team. This role will be based at our Trumbull, CT facility and can be a fully in-office or hybrid work arrangement.

Quality Assurance, Document Control - General

• Assist with Quality Systems Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts).

• Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc.

• Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization.

• Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise) and compliance with internal standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents.

• Maintain document security.

• Coordinate Periodic Review of Documents to owners.

• Upload existing/new revision documents to the PLM.

Training

• Conduct training for new and existing employees on electronic quality management system.

Audits

• Locate, review, submit, and reconcile document/record requests during audits.

• Ensure timely response to documentation requests for audits.

• Prepare welcome packet folders for upcoming audits.

Other duties

• Other duties as defined by management.

Minimum Required:

• High School Diploma/GED; a bachelor's degree is a plus.

Other Required

• 2-5 years of experience with ISO13485 standards.

• Ability to meet deadlines and perform administrative functions.

• Microsoft Office suite proficiency preferred.

• Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs.

• Ability and willingness to travel between locations when business needs dictate.

• Able to travel both domestically and internationally including overnight stays.

• Must be able to read, write, speak, fluently and comprehend the English language.

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.

#LI-EC1

#CSIH