Principal Quality Process Engineer
CooperCompaniesConnecticut, United States
Posted October 27, 2025
Full Time
About the Company
CooperCompanies (Nasdaq: COO) is a global medical device leader with two business units: CooperVision, which specializes in contact lenses; and CooperSurgical, focused on fertility and women's healthcare. The company operates in over 130 countries, impacting fifty million lives annually through innovative products like IVF devices and vision correction solutions. Known for its dedication to innovation, health and wellness, and community support, CooperCompanies is recognized as a U.S. Great Place to Work and is committed to meeting evolving healthcare needs.
Job Description
CooperSurgical is seeking a Principal Quality Process Engineer to lead initiatives to maintain and improve their Quality Management System (QMS) and ensure regulatory compliance. This role involves developing and implementing quality processes, supporting audits, conducting risk assessments, and driving process improvements based on metrics and data.
Requirements
- Lead initiatives to maintain and improve the Quality Management System (QMS) in compliance with FDA Quality Systems Regulations (QSR), ISO 13485, EU MDR, and other applicable regulations.
- Develop, implement, and maintain quality processes, procedures, and metrics to ensure consistent product quality and regulatory compliance.
- Support internal and external audits.
- Lead risk assessments (FMEA, Fault Tree Analysis).
- Monitor and report on quality metrics and trends.
- Author and review controlled documents.
- Mentor and train junior engineers and quality staff.
- Serve as a SME in quality process engineering.
