Quality Assurance Engineer 2 (Alajuela, Costa Rica)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This role is focused on the expanding portfolio of ENT (Ear, Nose, and Throat) technologies at Smith+Nephew, which includes advanced high frequency electrosurgical devices and systems, as well as small, handheld electronic devices used for innovative medical treatments and drug delivery.

Requirements

• Provide quality guidance and expertise to project teams as the quality engineering representative.
• Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.
• Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, Post Market Surveillance activities, and risk management documentation.
• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
• Ensure compliance to product specific standards, including, though not limited to cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and MDR requirements.

Benefits

• Stock purchase program
• Referral bonus
• Subsidy in transport and food
• Recognition program
• Extra days off
• Birthday off
• Voluntary hours
• Company doctor
• Medical insurance
• Gym
• Health campaigns
• Employee assistance program
• Parental leave