Job Description

Noah Medical is seeking a Sr. Quality Engineer to establish and support quality processes related to NPI, Design Transfer, and Post Market Support, specifically for the Service organization. This role involves ensuring compliance, supporting CAPA, and collaborating with various teams to improve product quality and serviceability.

Responsibilities

• Support root cause analysis and CAPA
• Develop and maintain quality documentation (SOPs, FMEAs)
• Monitor Quality KPIs and contribute to risk management
• Ensure compliance with FDA, ISO, and company standards
• Support internal audits and regulatory readiness
• Collaborate with service teams to evaluate issues
• Provide tools, training, and documentation to service teams
• Assist in software validation activities
• Participate in process improvements using Lean and Six Sigma
• Communicate feedback for design improvements
• Conduct quality reviews of new product launches

Requirements

• Bachelor’s degree in Engineering or related Science
• 5+ years in Quality Engineering (medical devices or robotics preferred)
• Strong knowledge of GxP, FDA regulations, IEC 62353, and ISO standards
• Experience with CAPA, risk management, and validation
• Proficiency with quality and business systems (Salesforce, Arena, Jira)
• Excellent communication and problem-solving skills
• CQA or Six Sigma certification preferred
• Project management experience preferred

Benefits

• No benefits