Design Quality Engineer 2 (Alajuela, Costa Rica)

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

The Design Quality Engineer 2 is responsible for implementing, supporting, and sustaining elements of Smith and Nephew's quality system. Under the guidance and direction of the Quality Engineering Manager, ensures that medical device regulations, standards, and guidelines are complied with through execution of Smith and Nephew procedures. Determines methods, techniques, and evaluation criteria for medical devices. Serves as a key resource for ISO, EN, MDD, EU MDR, and QSR requirements.

This position is level P2* Only for internal Candidates

What will you be doing?

• 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.
  

What will you need to be successful?

Successful candidates would need the following:

Education:

• 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

Physical Demands:

• 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

You. Unlimited

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/

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…

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