Senior Quality Engineer

About Cooper Surgical

Cooper Surgical 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 Cooper Companies, 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. Learn more at

Work location:

Trumbull, CT (on-site)

Scope:

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.

Job Summary:

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.

* Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management.

* Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.

* Lead and support nonconformance handling, deviations, disposition, and approval of nonconforming product.

* Support site leadership during internal and external audits and inspections; act as a subject matter expert during FDA, notified body, and supplier inspections.

* Analyze quality metrics and trends; drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

* Provide mentorship and technical guidance to junior quality engineers and quality inspectors.

* Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and other groups to ensure product quality and compliance throughout the product lifecycle.

* Lead reportable complaint investigations and coordinate activities with other stakeholders (DQA, PMS, etc.).

* Where necessary, support supplier quality activities, including supplier qualification, performance monitoring, and issue resolution.

* Serve as quality representative on cross-functional teams for new product introduction (NPI), design transfer, and manufacturing scale-up.

* Participate in other projects as required by quality management.

* Perform other duties as assigned.

Travel: this position may require 10-20% domestic and/or international travel.

Knowledge, Skills and Abilities:

* In-depth knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards.

* Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).

* Hands-on experience with process validation, CAPA, nonconformance management, and change control.

* Strong time management skills to drive multiple projects to completion on time.

* Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).

* Strong data analysis, negotiation, and problem-solving skills.

* Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.

* Experience in participating in regulatory audits/inspections is required.

* Proficient in reading, writing, and communicating in the English language.

Work Environment:

* Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.

* Occasionally lift to 35 pounds.

Experience:

* 5+ years of experience in medical device or healthcare industry related experience.

* 5+ years of quality systems background experience (NCMRs, CAPAs, Validations, Change Control, Training)

* 5+ years of experience in Quality Management/Quality Systems/Audit Program Management

* Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.

Education:

* Bachelor's degree in a health, Engineering or Science field required;
Advanced degree preferred.

* Certified Lead Auditor (ISO 13485:2016) is preferred.

* ASQ or equivalent certification and/or relevant work experience is strongly preferred. Other Professional…