As a Senior Quality Engineer, New Product Introduction, you will play a key role in bringing new medical technologies into production while ensuring quality, compliance, and process reliability. You will partner with cross-functional teams and suppliers to support product development, manufacturing transfers, process validation, and post-launch monitoring across the product lifecycle.

What You Will Do

• Lead risk assessments and define preventive and detective quality controls across incoming materials, manufacturing processes, and product release activities.
• Develop, validate, and maintain inspection methods, including measurement system analysis (Gage R&R), accuracy verification, and supplier correlation studies.
• Lead supplier component qualification activities through Production Part Approval Process (PPAP) and verify implementation of quality controls at supplier sites.
• Develop and execute process validation strategies, including statistical rationale, sample size justification, performance qualification activities, and worst-case condition testing.
• Partner with engineering teams to support product design transfers and manufacturing transfers, ensuring compliance with design control and regulatory requirements.
• Develop and execute sterilization validation activities in collaboration with subject matter experts, including documentation of validation outcomes.
• Monitor post-launch product performance by analyzing quality metrics, reporting process indicators, and leading investigations, corrective actions, and preventive actions for nonconformances.
• Train quality personnel and support internal and external audits while maintaining compliance with applicable quality and regulatory requirements.

What You Will Need

Required:

• Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Engineering, or a related technical field.
• Minimum 4 years of experience in Quality Engineering, Manufacturing Engineering, New Product Introduction, or Process Validation within a regulated industry.
• Experience applying process validation principles in accordance with FDA Quality System Regulation and ISO standards.
• Fluent English and Spanish (written and spoken).
• Experience with Production Part Approval Process (PPAP), risk management methodologies, and supplier quality activities.
• Experience using statistical tools and methods, including hypothesis testing, process capability analysis, design of experiments (DOE), and data interpretation.

Preferred:

• Experience supporting sterilization validation and sterile packaging processes.
• Experience working with manufacturing transfers, design transfer activities, and medical device quality systems.

• Puerto Rico: $69,500 - $110,900 USD Annual