Principal Quality Assurance Engineer

Your role:

• Plans and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
• Leads quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability. Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.

You're the right fit if:

• Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 5+ years of experience with Bachelor's in areas such as Medical Device, Design Quality Assurance, Risk Management, Quality Control, Quality Audit, or equivalent.
• We prefer 8+ years of experience with medical device regulations and standards, Design Quality Management, Design for Quality, Root Cause Analysis, CAPA Methodologies, Data Analysis.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.