Senior Quality Engineer

CooperCompanies • Trumbull, CT

13h • Onsite

About The Position

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. The Quality Engineer Sr will develop, maintain, and improve the Trumbull Quality Management System to ensure compliance with all relevant international standards and business requirements: FDA guidance, 21 CFR Part 820, ISO 13485:2016, MDSAP and others as applicable. This position will also provide overall quality assurance leadership in the production of Cooper Surgical products and drive the operational quality culture at the manufacturing process level. The Quality Engineer Sr will be responsible for ensuring the highest standards of quality throughout our organization and provide strategic thinking with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.

Requirements

• Deep understanding of quality management systems
• Deep understanding of change control processes
• Proven track record of implementing and maintaining robust quality processes
• Knowledge of FDA guidance
• Knowledge of 21 CFR Part 820
• Knowledge of ISO 13485:2016
• Knowledge of MDSAP

Responsibilities

• Develop, maintain, and improve the Trumbull Quality Management System to ensure compliance with all relevant international standards and business requirements: FDA guidance, 21 CFR Part 820, ISO 13485:2016, MDSAP and others as applicable
• Provide overall quality assurance leadership in the production of Cooper Surgical products
• Drive the operational quality culture at the manufacturing process level
• Ensure the highest standards of quality throughout the organization
• Provide strategic thinking with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees