Proactive and goal-oriented professional with over 18 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.
Managed and maintained strong relationships with suppliers to ensure compliance with quality standards.
Oversaw documentation processes for over 1200 suppliers, ensuring accurate and timely record-keeping.
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.
Collaborated with SQE's and Sourcing SME's to onboard new suppliers to the approved vendor list.
Supported all on-site audits by FDA and international regulatory agencies .