What are the responsibilities and job description for the Quality Assurance Coordinator position at Cooper Companies?
Job Description
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.
Responsibilities
- 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 center's 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.
Qualifications
Travel : Not applicable.
Our Benefits :
As an employee of CooperSurgical, you'll 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 www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies : Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms / employment agencies to any employee at CooperSurgical via-email, the internet or in any form and / or method will be deemed the sole property of CooperSurgical, unless such search firms / employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
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.
