Quality Assurance Coordinator

About CooperSurgical:CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to womens healthcare providers, including testing and treatment options. CooperSurgical is a wholly owned subsidiary of Cooper Companies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at . Work location: Dallas Fort Worth, TX. This is an on-site position, five days a week, from Monday to Friday. Flexibility to work additional hours or weekends may be required based on business needs. Scope/Summary: The Quality Assurance Coordinator is integral to maintaining and supporting quality assurance processes within the medical device distribution center. This role ensures compliance with Good Manufacturing and Distribution Practices, ISO 13485 standards, and company quality and regulatory requirements. The coordinator is responsible for executing tasks assigned by the Quality Assurance Supervisor to uphold the effectiveness of the Quality Management System. Additionally, they act as a key collaborator in preserving quality compliance and driving continuous quality system improvement initiatives across the Distribution Center. This role requires close collaboration with cross-functional teams to address quality concerns and ensure proper evaluation and handling to maintain quality standards in compliance with Good Distribution and Manufacturing Practices. The Quality Assurance Coordinator serves as a key point of contact for quality-related activities, contributing to consistent compliance to guarantee that the quality, integrity, and safety of the products are maintained throughout the distribution center's operations. Essential Functions & Accountabilities:Performs assigned daily tasks effectively, on time and in compliance with Good Distribution Practices. Performs the incoming quality inspection process to verify that received materials meet quality standards. Maintain the Quality Order process, ensuring accurate records, documentation, and timely release. Conduct the Return Material Authorization (RMA) process, ensuring returned materials are inspected, received, and appropriately dispositioned. Collaborate with cross-functional teams to address quality concerns and drive continuous improvement. Support the maintenance of the Quality Management System in compliance with ISO 13485 standards and regulatory requirements. Conduct assigned non-routine inspections on finished goods, comparing results with company quality standards, and communicating and addressing any findings as necessary. Performs product inspections at various stages of the Distribution process including visual inspection as well as Cycle counts. Generate Non-Conformance Material Reports (NCMRs) when inspection results indicate deviations or when significant quality issues are identified. Act as a resource for other departments on quality-related issues. Participate in cross-functional meetings to facilitate information exchange, troubleshoot issues, and provide quality assurance recommendations. Maintain proper documentation control, including updates to procedures, work instructions, and records. Identify areas for process improvements and support the implementation of changes to enhance the effectiveness of the quality system and ensure product quality. Support the monitoring of the Temperature Monitoring System within the distribution centers temperature-controlled areas. Perform other duties or assignments as required by the Quality Assurance management team. Foster a culture of quality and continuous improvement within the distribution center. Education and Experience:Must possess a high school diploma or GED. Minimum of 3 years of experience in Quality Assurance or a related field within the medical devices distribution, pharmaceuticals, or life sciences industry. Certifications in Quality System, ISO 13485 are preferred. Experience with cold chain management and temperature monitoring systems is a plus. Proficiency in Microsoft Office Suite, D365 ERP, and other relevant applications are preferred. Experience in healthcare, medical devices, or other regulated industries operating under FDA regulations is highly preferred. Good communication skills, results-driven, innovative, creative, and action-oriented Critical thinking and decision-making skills, with the ability to multitask in a fast-paced environment Ability to review and comprehend written instructions, including specifications and quality inspection methods and requirements. Travel: Not applicable. Our Benefits:As an employee of CooperSurgical, youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Created: 2025-02-20