Quality Manager

Location

Irving, TX | United States

Job description

Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.

Our Operating Room Disposables Division, located in Irving, Texas is seeking a Quality Manager. Working in partnership with some of the world's leading medical device manufacturers, Repligen Operating Room Disposables Division has developed and manufactured a full line of single use, sterile products for a wide range of clinical applications.

1. Assuring acceptable quality of Repligen, Operating Room Division products and processes
2. Assuring compliance with FDA, ISO 13485 and 21CFR820 requirements by document control, audits and Corrective Actions
3. Writing documentation and performing training on GMP, ISO and CE compliance.
4. Planning, Coordination, Execution and follow-up of internal audits
5. Recording the issue, amendment and withdrawal of controlled documents
6. Ensuring implementation of corrective actions and control of all changes to the Quality Management System
7. Acting as liaison between Production and Engineering Departments
8. Correspondent between Repligen, ORD and Regulatory Agents
9. Assuring compliance with regulatory standards
10. Authorization of action/responses to customer complaints
11. Assuring final release of conforming product prior to distribution
12. Maintaining ISO/EN/MDD certification and surveillance documentation
13. Preparation and submission of product applications to government agencies (e.g. 510K)
14. Complaint handling and vigilance reporting
15. Coordinating regulatory submissions and product approval, assessing the impact of design changes on regulatory status and determining the compliance with essential requirements
16. ISO 13485 Management Representative performing Management Review
17. Member of the Repligen ORD Division Management Committee
18. Other duties as assigned by the VP/General Manager

MINIMUM QUALIFICATIONS AND EXPERIENCE REQUIREMENTS

• Bachelor’s degree or equivalent
• 7-10 years’ experience in Medical Device Quality Management Systems (e.g. ISO 13485, CMDCAS)
• Experience working with Notified Bodies and solid understanding of CE Mark process
• Understanding of EU MDR Requirements strongly desirable

Job tags

Salary