Design Quality Engineer 2 (Alajuela, Costa Rica)

• Generate/approve/manage post market surveillance and risk management activities. 
• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and EU MDR requirements.
• Provide quality oversight and leadership for quality related issues (e.g. non-conforming material, corrections, deviations, CAPA, etc.). Investigates, documents and leads corrective/preventive actions. 
• Provide quality support to product support project teams as the quality engineering representative. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation. 
• Support Management Review, and internal and external audits/inspections. 
• Assist in other responsibilities requested by management to ensure compliance. 
• Analyze post market surveillance data, identify trends and verify products are performing within established risk profiles. 
• Perform routine updates of product risk management files. 
• Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions. 
• Lead review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products. 
• Assist in preparation and coordination of Internal and External audits. 
• Establish and maintain cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments. 
   

• Bachelor's degree in engineering 

Experience:

• 2 years minimum experience in the medical device or related industry 
  

Competencies:

• Sound decision-making with attention to detail; understanding of regulatory requirements (GMP, ISO 13485, ISO 14971, MDD, EU MDR)
• Ability to provide and implement solutions to quality problems
• Ability to plan and schedule multiple projects
• Effective written/oral communication skills
• Team player
• MS Office, MS Excel, and statistical software proficiency

• Weightlifting: Light (0kg - 10kg)                                               
• Position: Mostly sitting / Mostly Computer                                                   
• Repetitive Motion: Low:<10 moves/30sec                                             
• Chemical Exposure: No chemicals exposure or cleaning use only   
• Physical Risk (Personal Protective Equipment – PPE) ocasional Use required         

• 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…