Design Quality Engineer 2 (Medical Devices)

About the role

Smith & Nephew is looking for a Design Quality Engineer 2 in Alajuela, Costa Rica, to implement, support and sustain elements of its quality system under the guidance of the Quality Engineering Manager. The engineer ensures compliance with medical device regulations, standards and guidelines, determines evaluation methods for medical devices and acts as a key resource for ISO, EN, MDD, EU MDR and QSR requirements. This is a Level P2 position open only to internal candidates.

Key responsibilities

• Manage post-market surveillance and risk management activities, and update product risk management files
• Ensure compliance with cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and EU MDR requirements
• Provide quality oversight for non-conforming material, corrections, deviations and CAPA, and lead corrective and preventive actions
• Support product support project teams as the quality engineering representative
• Generate and manage design verifications, design validations, sterilization and process validations, supplier qualifications, test methods, capability studies and risk management documentation
• Support management reviews and internal and external audits, and coordinate audit preparation
• Analyze post-market surveillance data, identify trends and verify products perform within their risk profiles
• Lead review and disposition of discrepant components, materials, sub-assemblies and finished products
• Maintain cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality and Regulatory Affairs

Required profile

• Bachelor's degree in engineering
• At least 2 years of experience in the medical device or a related industry
• Understanding of regulatory requirements such as GMP, ISO 13485, ISO 14971, MDD and EU MDR
• Sound decision-making with attention to detail, ability to solve quality problems and to plan and schedule multiple projects

Required skills

• Proficiency in MS Office and MS Excel
• Statistical software

What we offer

• Stock purchase program, referral bonus, transport and food subsidies, recognition program
• Extra days off, birthday off and voluntary hours
• Company doctor, medical insurance, gym, health campaigns, employee assistance program and parental leave
• Hybrid work model for more professional roles, flexible schedules and training programs