Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Preferred Six Sigma Green Belt certification.
• Experience with Design Control, Design Verification & Validation (DV/V), Process Validation, Risk Management, CAPA, RCA, PMS, and medical-device/regulatory quality is preferred.
• No prior experience is mandated for candidates with a Master's degree.
• Strong understanding of quality assurance principles in regulated environments.

Responsibilities

• Manage the Design Control process from design inputs through verification, validation, and design transfer.
• Develop and execute process validation strategies using statistical/data-analysis methods.
• Prepare and maintain Quality Plans and other quality engineering documentation.
• Perform Design Verification (DV) and Design Validation (PV) planning and support execution.
• Review product/system designs for quality, reliability, safety, performance, and manufacturability.
• Perform Root Cause Analysis (RCA) for product and quality issues.
• Manage CAPA activities, including investigation, corrective action, and effectiveness checks.
• Support Risk Management/Risk Assessment throughout the product lifecycle.
• Use Post-Market Surveillance (PMS) data to identify product quality issues and improvement opportunities.
• Collaborate with R&D, Manufacturing, Regulatory, Quality, and external stakeholders.

Benefits

• Opportunity to work on varied projects throughout the complete product lifecycle.
• Engagement with cross-functional teams, enhancing collaboration skills.
• Potential for professional development in regulatory compliance and quality engineering.
• Involvement in cutting-edge medical device technologies.
• Contribution to improving healthcare outcomes through quality assurance.