Senior Quality Engineer, New Product Introduction

Stryker • Arroyo, PR

13d • Hybrid

About The Position

Support the design and testing of new products. Ensure that everything functions well and meets quality standards. Identify and prevent potential problems (especially risks, defects, and inspection issues). Ensure the product can be manufactured efficiently and safely. Support validations (process, tool, and equipment testing). Assist in the selection and approval of suppliers for new components or processes. Lead quality activities during design transfer (when the product moves from design to production). Work closely with engineering and manufacturing teams to ensure product quality and manufacturability.

Requirements

• University degree in engineering (or similar).
• At least 2 years of experience in regulated industries, such as medical devices or pharmaceuticals.
• Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections.
• Knowledge of standards such as ISO 13485 (quality standard for medical devices).
• Advanced English communication skills (oral and written).

Nice To Haves

• Experience with Process Flow Mapping (PFM) or process risk assessment.
• Experience with non-conformity management.
• Experience with supplier quality initiatives.

Responsibilities

• Support the design and testing of new products.
• Ensure that everything functions well and meets quality standards.
• Identify and prevent potential problems (especially risks, defects, and inspection issues).
• Ensure the product can be manufactured efficiently and safely.
• Support validations (process, tool, and equipment testing).
• Assist in the selection and approval of suppliers for new components or processes.
• Lead quality activities during design transfer (when the product moves from design to production).
• Work closely with engineering and manufacturing teams to ensure product quality and manufacturability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees