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.

This position will implement, support, and sustain elements of Smith & Nephew’s Quality System through design testing, protocol/report generation, training, and technical support.

The Quality Assurance Engineer determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for the following, though not limited to: ISO, EN, MDD, MDR and QMSR requirements.

This position is a P2 level 

What will you be doing? 

• 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. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.

• Support continuous improvement activities (CAPA/NC/Internal Audit, etc.).

What will you need to be successful?  

Education: Bachelor’s degree in Engineering, or related field.

Languages:

• Excellent English proficiency is a must.

Experience:

• +2 years of professional experience within the medical device, pharmaceutical, or other regulated medical/healthcare industries.

• Proficiency working within multiple PLM systems (Agile, Arena, Smartsolve, Windchill)

• Proactive engagement with suppliers / contract manufacturers to generate solutions to quality / operational challenges.

Leadership if any:

• No experience managing a team required

• Experience providing guidance to technicians / operators preferred

• Travel Requirements: <5%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion+belonging: Committed to Welcoming, Celebrating and Thriving, learn more about employee inclusion groups on our website

Other reasons why you will love it here!

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.

• Work/Life Balance: Extra days off, birthday off, voluntary hours.

• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 

• Flexibility: Hybrid work model (for more professional roles), flexible schedules.

• Training: Training program, unlimited learning.

• Extra perks: employees association, and more…