Quality Assurance Medical Device Specialist

hace 6 días


San José, San José, Costa Rica Smith+Nephew A tiempo completo
Company Overview

At Smith+Nephew, we strive to create a positive impact on society. Our organization is built around the core values of creating the greatest good for patients and employees alike.

We are committed to fostering an inclusive and diverse environment where everyone feels valued and empowered to contribute their best work. Learn more about our commitment to Inclusion, Diversity, and Equity on our website.

Job Description

Role Summary: The Design Quality Engineer I plays a crucial role in implementing, supporting, and sustaining elements of Smith+Nephew's quality system. As a key member of the team, you will ensure that medical device regulations, standards, and guidelines are complied with through execution of Smith+Nephew procedures.

Main Responsibilities:

  • 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.
Required Skills and Qualifications

To be successful in this role, you must possess the following skills and qualifications:

  • Bachelor's degree in engineering or related field.
  • Advanced English language proficiency.
  • Minimum 1 year of experience in the medical device or related industry.
  • 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.
Benefits

Smith+Nephew offers a comprehensive benefits package designed to support your well-being and success:

  • Stock purchase program.
  • Referral bonus.
  • Subsidy in transport and food.
  • Recognition program.
  • Extra days off.
  • Birthday off.
  • Voluntary hours.
  • Company doctor.
  • Medical insurance.
  • Gym.
  • Health campaigns.
  • Employee assistance program.
  • Parental leave.
  • Hybrid work model (for more professional roles).
  • Flexible schedules.
  • Training program.
  • Unlimited learning.


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