Quality Assurance Supervisor

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 Supervisor will oversee the quality assurance processes for the medical device distribution center, ensuring compliance with good manufacturing and distribution practices, ISO 13485 standards, and company quality and regulatory requirements. This role includes managing the quality team, maintaining the effectiveness of the Quality System, and acting as the primary point of contact for quality compliance and continuous quality system improvement initiatives within the Distribution Center. The Quality Assurance Supervisor is a key leadership role within the Distribution Center Operations, responsible for ensuring Good Distribution Practices are executed per defined quality standards established under ISO 13485 and meeting regulatory requirements established under FDA regulations. This ensures that the Distribution Center personnel and activities remain in compliance with local and international regulatory requirements to meet GMPs and GDPs standards. This position, while organized within the Quality Assurance department, will work with the broader Global Quality Operations group and will be required to collaborate regularly cross-functionally with other departments such as Warehouse Operations, Customer Service, Commercial, Sales, Marketing, Manufacturing, Supply Chain, Procurement, Planning, Finance, Transportation, and Trade Compliance. Essential Functions & Accountabilities:Lead and manage the Quality Assurance team to ensure daily tasks are executed effectively and on time. Supervise the incoming inspection process to verify that received materials meet quality standards. Manage the Quality Order process, ensuring accurate documentation and timely release. Manage the Return Material Authorization (RMA) process, ensuring returned materials are inspected and appropriately dispositioned. Coordinate with internal teams to resolve RMA issues effectively. Provide training, coaching, and performance evaluations for quality personnel to build a high-performing team. Collaborate with cross-functional teams to address quality concerns and drive continuous improvement. Oversee the implementation and maintenance of the Quality Management System in compliance with ISO 13485 standards and regulatory requirements. Ensure proper documentation control, including updates to procedures, work instructions, and records. Plan and conduct internal audits, ensuring timely resolution of audit findings. Manage corrective and preventive actions (CAPA) and ensure effectiveness. Ensure all operations within the distribution center meet Good Manufacturing and Distribution Practices per ISO 13485 requirements. Monitor adherence to quality policies and procedures, providing training and guidance to ensure compliance. Identify areas for process improvements and implement changes to enhance efficiency and guarantee product quality. Analyze quality data and trends to develop strategies for reducing non-conformance and improving quality assurance. Drive initiatives to streamline quality assurance processes and mitigate costs while maintaining high quality standards. Foster a culture of quality and continuous improvement within the distribution center. Conduct risk assessments and mitigation planning for quality-related processes within the distribution center. Oversee and conduct non-routine inspections, addressing any findings as necessary. Develop and/or approve Standard Operating Procedures (SOPs) and oversee change control processes to ensure compliance with GMP quality standards. Participate in supplier contract reviews, including Quality and Supplier Agreements. Collaborate on cross-functional projects to improve cold chain management, optimize temperature monitoring systems, enhance product conditions during the distribution process, and promote operational excellence through targeted training initiatives. Supervise the monitoring and calibration of the Temperature Monitoring System within the distribution centers temperature-controlled areas. Communicate quality standards updates and expectations to internal teams and stakeholders. Develop goals and objectives for the Quality Assurance department, ensuring continuous improvement of the Quality System. Establish key performance indicators (KPIs) to measure team performance and quality assurance metrics. Prepare and present quality performance metrics and reports to senior management. Ensure all quality policies and procedures are implemented and managed throughout the distribution centers operations. Manage product holds and quarantine areas for defective or suspect products until they are cleared or disposed of appropriately. Maintain a comprehensive training matrix and records to demonstrate compliance with regulatory requirements. Collaborate with all areas of the business to develop strategies to continuously improve customer experience while meeting local regulations and Good Distribution Practices. Education and Experience:Bachelor's degree in quality assurance, engineering, life sciences, or a related field is required. Certifications in Quality System, ISO 13485, and Lead Auditor are preferred. Minimum of 3 years of experience in Quality Assurance or a related field within the medical devices distribution, pharmaceuticals, or life sciences industry. Experience with cold chain management and temperature monitoring systems is a plus. Experience in supporting audits, CAPA management, and risk assessments are preferred. Demonstrated leadership capabilities with a proven track record of effectively managing and developing high-performing quality teams. Proficiency in Microsoft Office Suite, D365 ERP, and other relevant applications is preferred. Experience in healthcare, medical devices, or other regulated industries operating under FDA regulations is highly preferred. Results-driven, innovative, creative, and action-oriented; capable of aligning and energizing teams around common objectives within both reporting and non-reporting structures. Demonstrates strong critical thinking and decision-making skills, with the ability to solve complex problems and develop innovative solutions that drive results for the organization. Travel: This role may require up to 15% travel including domestic and international. 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: 2025-02-19