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 wit

📌 Senior Quality Engineer, New Product Introduction (Arroyo de la Luz)
🏢 Stryker
📍 Arroyo de la Luz