Quality Engineer (Medical Devices)

About the role

Johnson & Johnson is seeking a Quality Engineer to join its MedTech Cardiovascular team in Grecia, Costa Rica. The role focuses on ensuring medical device products meet the highest quality standards throughout their lifecycle.

Key responsibilities

• Participate in new product and process teams to develop quality‑engineered systems and products.
• Lead and support design verification testing and process validation activities.
• Ensure compliance with Johnson & Johnson Quality System policies and external regulations such as FDA, ISO 13485, and MDSAP.
• Drive quality‑assurance activities to maintain effective product quality processes.
• Collaborate with R&D, Engineering/Technical Operations, Quality, and Operations teams.

Required profile

• Ability to work independently and develop technical solutions for complex problems.
• Strong collaboration skills across multidisciplinary teams.

Required skills

• Knowledge of FDA regulatory requirements for medical devices.
• Familiarity with ISO 13485 quality management standards.
• Understanding of MDSAP requirements.
• Experience with design verification and process validation methods.