Responsibilities:

• Develop and conduct process and equipment validation and verification activities, including risk assessments.
• Communicate with suppliers and contract assembly facilities to ensure a coherent product quality system.
• Construct a systematic approach to understanding outgoing product quality using sampling plans and non-destructive testing.
• Perform root cause analysis on quality issues and non-conformances, and implement corrective and preventive actions.
• Maintain accurate documentation related to quality activities, including inspection records, test results, and audit reports.

Requirements:

• Bachelor’s degree in Engineering
• 2+ years of experience in quality engineering within a manufacturing environment; medical device industry experience preferred.
• Sense of mechanical intuition and ability to quickly understand complex electro-mechanical systems.
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, team-oriented environment.
• Strong organizational and project management skills, with attention to detail.