Quality Engineer II

Responsibilities

• Lead the development of risk assessments and test methods
• Support component qualifications, design validation/verification, and process validation
• Lead basic level product investigations and assess product changes against design
• Represent Quality Engineering on Product Development Teams
• Translate "Voice of the Customer" into design requirements and manufacturing control plans
• Apply Quality Engineering tools including sampling plans, root cause analysis, and statistics
• Support internal and external supplier audits and regulatory requirements (MDSAP/EUMDR)
• Prepare and present project updates and technical discussions

Requirements

• Bachelor's degree in a STEM field with at least 2 years of engineering experience in medical devices or a regulated industry, OR a Master's degree in a STEM field with relevant engineering experience
• Proficiency in statistical and risk assessment techniques
• Experience with test method development, validation, and equipment qualifications
• Solid understanding of FDA GMP/GLP, ISO standards, and other regulatory requirements (ASTM, AAMI, etc.)
• Strong problem-solving skills and the ability to lead multi-functional teams
• Excellent oral and written presentation skills

Preferred Qualifications

• Quality Engineering Certification (ASQ) or equivalent

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we strive to find transformative solutions that turn dreams into possibilities through design, engineering, and manufacturing.