CooperSurgical · 2 hours ago
Principal Quality Process Engineer
Trumbull, CT
Full-time
Onsite
Lead/Staff
10+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Principal Quality Process Engineer will lead initiatives to maintain and improve the Quality Management System, ensuring compliance with relevant regulations and driving quality improvements.
Health CareMedical DeviceWomen's
Responsibilities
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, including but not limited to FDA, ISO, and notified body inspections
Lead risk assessments (FMEA, Fault Tree Analysis) for new and existing processes
Drive root cause analysis and corrective/preventive actions (CAPA) for process-related nonconformances and complaints
Monitor and report on quality metrics and trends to identify areas for improvement
Author and review controlled documents including SOPs, work instructions, validation protocols/reports, and engineering specifications
Support change control processes for validated systems, equipment, and test methods
Mentor and train junior engineers and quality staff on quality engineering principles and regulatory requirements
Serve as a subject matter expert (SME) in quality process engineering during cross-functional meetings and project reviews
Perform and participate in other projects at the discretion of management
Qualification
Required
Proven experience with medical devices, combination products, and pharmaceuticals
Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR
Expertise in process validation, statistical analysis, and quality tools
Proficiency in quality software systems
Strong analytical, problem-solving, and project management skills
Excellent communication and leadership abilities
Experience in Lean Six Sigma and Lean Manufacturing principles
Minimum 10 years of experience in Quality Engineering or Process Engineering in the medical device and / or pharma industry
Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related field)
Preferred
Master's degree preferred
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal
Sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
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2025-08-29
2025-08-27
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