Quality Assurance Engineer

hace 1 semana


San José, San José, Costa Rica Smith+Nephew A tiempo completo
About Smith+Nephew

At Smith+Nephew, we design and manufacture innovative medical technology that takes the limits off living. Our mission is to create the greatest good for society by investing in our people and the patients we serve.

Job Summary

We are seeking a highly skilled Quality Assurance Engineer - Medical Devices to join our team. As a key member of our quality function, you will be responsible for ensuring compliance with regulatory requirements and standards.

Key Responsibilities:
  • Implement and sustain elements of Smith+Nephew's quality system, ensuring compliance with medical device regulations and standards.
  • Determine methods, techniques, and evaluation criteria for medical devices, serving as a key resource for ISO, EN, MDD, EU MDR, and QSR requirements.
  • Work with suppliers to ensure changes related to latest regulatory requirements have been implemented, as required.
  • Assist Operations during manufacturing cutover to reduce scrap costs and ensure compliance.
  • Support compliance initiatives related to Operations, Engineering, and Quality functions.
  • Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures.
Requirements

To succeed in this role, you will need:

  • Bachelor's degree in engineering or a related discipline.
  • Minimum 2 years' experience in the medical device or related industry.
  • Advanced English language skills.
  • Able to make decisions with attention to details and understand the impact of regulatory requirements on Smith+Nephew's products.
  • Ability to provide and implement solutions to quality problems.
  • Effective written and oral communication skills, as well as team player abilities.
  • Proficiency in MS Office, MS Excel, and statistical software.
What We Offer

As a Quality Assurance Engineer - Medical Devices at Smith+Nephew, you can expect:

  • An estimated annual salary of $85,000-$105,000 based on location.
  • A comprehensive benefits package, including company doctor, medical insurance, gym, health campaigns, employee assistance program, and parental leave.
  • Flexible work arrangements, including hybrid work model and flexible schedules.
  • Training and development opportunities through our training program and unlimited learning resources.
  • Extra perks, such as an employees association and more.


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