Quality Engineer – Profile Summary

Experienced and detail-oriented Quality Engineer with a strong background in medical device manufacturing, specializing in injection molding processes. Skilled in the application of Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP) methodologies to ensure product compliance and process stability from design through production.

Proven ability to function as a supplier liaison, ensuring supplier quality standards meet internal and regulatory requirements. Demonstrated success in managing customer quality concerns, facilitating root cause analysis, corrective actions, and continuous improvement initiatives. Adept at working in regulated environments, with a solid understanding of ISO 13485 and FDA 21 CFR Part 820 compliance requirements.

Key strengths include:

• Cross-functional collaboration with engineering, manufacturing, and supply chain teams
• Developing and implementing quality control plans and inspection procedures
• Leading process validations (IQ/OQ/PQ) for medical devices
• Managing NCRs, CAPAs, and supplier quality audits

Dedicated to maintaining high-quality standards and contributing to safe, effective, and compliant products in the medical device industry.