Principal Quality Engineer

Principal Quality Engineer

How You'll Make an Impact

As a Principal Quality Engineer, you will play a critical role in ensuring the successful transfer of products into manufacturing, driving risk management activities, and maintaining regulatory compliance. Your expertise will support both the development of new products and the optimization of existing ones, ensuring product safety, quality, and performance. By leading validations, overseeing sterilization and environmental monitoring programs, and partnering with cross-functional teams, you will help deliver life-changing medical therapies to patients.

What Will You Do?

• Product Transfer & Operations
  
  
  
  • Lead validations (IQ/OQ/PQ) and ensure new product processes meet high-quality standards.
  • Monitor inspection results and trends to ensure products meet specifications and performance criteria.
  • Oversee sterility assurance, including gamma sterilization processes, dose audits, and environmental monitoring.
  • Provide "quality on the floor" support, including analytical testing, gage R&R studies, and process optimization.
  
  
• Risk Management & Quality Systems
  
  
  
  • Maintain ISO 14971-compliant risk management files for all product lines.
  • Lead risk management activities and integrate risk analysis across the quality management system.
  • Support CAPA investigations, lead quality system improvements, and ensure documentation meets regulatory standards.
  • Participate in internal and supplier audits, close findings, and drive corrective/preventive actions.
  • Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
  
  
• Cross-Functional Leadership
  
  
  
  • Partner with R&D, Operations, and Manufacturing teams to enhance processes and optimize product quality.
  • Mentor team members on quality processes and technical problem-solving.
  • Support initiatives that facilitate the achievement of operational, regulatory, and clinical objectives.
  
  

How Will You Get Here?

• Bachelor's Degree in Engineering, Science, or related field.
• 12+ years of production or engineering experience, with 5+ years in medical device/pharma/combo product quality (10+ preferred).
• 3+ years of leadership experience (5+ preferred).
• Strong understanding of 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Experience with sterilization methods (gamma preferred), laboratory testing, and process validations.
• ASQ certifications (CQA, CBA, CQE) preferred.