Supplier Quality Regulatory Compliance

Debbie Davis

Maricopa, AZ *****

760-***-**** - *********@*****.***

Professional Summary

Proactive and goal-oriented professional with over 17 years of experience in quality coordination, and process improvement within the medical device industry. Recognized for strong time management, problem-solving, reliability and adaptability. Quick to learn and apply new skills, committed to driving team success and contributing to organization growth.

Knowledge of industry standards and regulatory compliance essential for maintaining high- quality outputs.

Work History

09/2007 to 04/2025 Quality Coordinator Sr.

Vyaire Medical Inc. – Palm Springs, CA

Managed and maintained strong relationships with suppliers to ensure compliance with quality standards.

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Oversaw documentation processes for over 1200 suppliers, ensuring accurate and timely record-keeping.

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• Maintained and updated supplier files, ensuring deadlines were consistently met. Conducted Supplier quality evaluations, verified credentials, calculated rejection rates, and managed nonconformance reports and CAPA's.

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Collaborated with SQE's and Sourcing SME's to onboard new suppliers to the approved vendor list.

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• Supported all on-site audits by FDA and international regulatory agencies . Early Career Experience

• Managed daily operations in fast-paced restaurant and retail environments Hired, trained, and supervised staff to ensure high performance and excellent customer service

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• Handled inventory control, scheduling, and cash management

• Resolved customer concerns efficiently, maintaining satisfaction and loyalty

• Maintained a clean, organized, and compliant work environment

• Developed strong communication, leadership, and multitasking skills Education

Business

Rubidoux - Rubidoux, CA

Skills

• Proficient in Excel, Word, and PowerPoint Proficient in Pointman, Made 2 Manage and SAP

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Supplier quality assessment & Record-

keeping proficiency

• Dedicated work ethic & Collaborative

teamwork

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• Well versed in Regulatory compliance Effective team collaboration and Effective time management

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Strong attention to detail, and strong

organizational abilities

• • Analytical problem-solving

• Proficient in managing multiple tasks • Trustworthy execution

• Problem-solving skills Effective team leadership, and Strategic decision making

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Inventory management and Quality

control management

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