Design Quality Engineer I (Coyol, Alajuela)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Are you passionate about quality? This position Engineer  is responsible for implementing, supporting, and sustaining elements of Smith and Nephew’s quality system.  Under the guidance and direction of the Design Quality Engineering Manager, he/she ensures that medical device regulations, standards, and guidelines are complied with through execution of Smith and Nephew procedures. The Design Quality Engineer  determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, EN, MDD, EU MDR, and QSR requirements.

This position is a P1 level

What will you be doing?

• Generate change records necessary for compliance to latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.).
• Provide quality oversight and leadership for product cutover to assure these are managed effectively.
• Work with suppliers to ensure compliance to latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) changes have been implemented.
• Support Management Review, and internal and external audits/inspections.
• Assist in other responsibilities requested by management to ensure compliance.

What will you need to be successful?

• Education: Bachelor’s degree in engineering or related field.
• Languages: Advanced English level.
• Experience: Minimum 1 year of experience in the medical device or related industry.
• Competencies: Able to make sound decisions with attention to details.
• Understanding the impact of regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) on Smith & Nephew’s products is necessary
• Able to provide and implement solutions to quality problems.
• Ability to plan and schedule multiple projects and tasks.
• Effective written/oral communication skills.
• Team player.
• MS Office, MS Excel, and Statistical software proficiency.

​You. Unlimited

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

Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, 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…