Staff Quality Engineer, New Product Introduction

Staff Quality Engineer role supporting new medical device development and manufacturing introductions. Provides technical quality leadership across design transfer, process validation, risk management, and supplier quality within a regulated environment.

Responsibilities

• Lead quality engineering activities for new product and process introductions with documentation aligned to regulatory requirements
• Conduct PFMEA and develop risk mitigation strategies per ISO 14971 standards
• Develop inspection strategies, sampling plans, and measurement system analysis approaches for manufacturing scalability
• Establish and validate process validation protocols, reports, and analyses supporting manufacturing capability
• Support supplier qualification, PPAP activities, and quality agreements for new product launches

Requirements

• Bachelor of Science in Engineering or related technical discipline
• Minimum 4 years quality, engineering, or technical experience
• Experience in regulated manufacturing environment
• Proficiency with FMEA, statistical sampling, process capability, and MSA techniques
• Medical device manufacturing knowledge including ISO 13485 and GMP (preferred)
• Certified Quality Engineer certification or equivalent (preferred)
• Lean Six Sigma training and DMAIC experience (preferred)

Compensation: $102,700 - $171,100 USD Annual