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Check with seller Quality Release Reviewer Bridgeport

Published date: April 3, 2022
  • Location: Bridgeport, Connecticut, United States

Position Summary:
This job description intends to depict minimum job functions and requirements. To describe product release activities. Quality Release Inspectors to ensure DHRs are properly handled, archived and disposed of per procedures for all products. This individual will be responsible for supporting the Quality Release department adhering to FDA 21 CFR regulations, ISO 13485 and cGMP

Essential Functions:
Inspect DHRs to ensure all pertinent information is present per procedures.
Coordinate the organization and management of scanning and completeness verification of Device History Records (DHR) for the Trumbull Manufacturing facility before lot release and to ensure documentation accuracy procedures are followed.
Coordinate finished goods release per the required Quality Management System (QMS) procedures. With care on final release of lots to authorize export to the sterilization supplier. And then verification of objective evidence to release sterilized products being transferred to the distribution center and authorize further released.
Works with production, engineering and quality engineering.
Performs tasks using good housekeeping practices and safety techniques.
Maintains 5S within the department
Performs other duties or assignments as required by management.
Facilitates third party audits, supporting management with documentation as needed.
Coordinates the scheduling for all physical DHRs that are stored at the approved off-site record storage facility and when needed will support management with documentation request.
Creates CoA, CoC, CoS, etc.

Qualifications:
Strong organizational skills
Working knowledge of Microsoft suite of products, including Excel, Word, PowerPoint and Outlook.
Ability to multitask in a fast-paced environment
Three or more years of experience in Quality Control positions.
Ability to review and comprehend written instructions, including blueprints, specifications, Device History Record and methods.
Knowledge of Device History, Device Master Records, GMP’s, and ANSI/ASQ Standards. As well as active experience in ISO or FDA audits.
Technical level education and experience in Medical devices, Electronics or Mechanical applications as well as High School Diploma.
At least 6 months working for CooperSurgical.
Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records
Proficient interpersonal skills and the ability to work effectively in a cross-functional team

Our Benefits:
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/dental/vision insurance coverage, 401(k), paid time off for vacation, personal, sick and holidays, paid family leave and many 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.

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

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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