Quality Engineer

Job Summary

Seeking an experienced Quality Engineer on a contract basis, the role will support quality assurance and manufacturing quality in FDA-regulated medical device environments, focusing on product development, validation, and continuous improvement activities.

Key Responsibilities

• Support quality engineering activities throughout the medical device product lifecycle, including design, manufacturing, testing, and release
• Develop, implement, and maintain quality systems and procedures in accordance with FDA, ISO 13485, and applicable regulatory requirements
• Lead and support CAPA, Non-Conformance Reports (NCR), deviations, complaints, and corrective/preventive actions

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Quality Engineering, or a related field
• 3+ years of Quality Engineering experience, preferably within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment
• Strong knowledge of FDA 21 CFR Part 820 / applicable FDA Quality System requirements and ISO 13485
• Experience with CAPA, NCR, deviations, complaint investigations, RCA, and change control
• Experience with Risk Management and FMEA