Senior Quality Assurance Engineering Leader

hace 11 horas


Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

Job Summary:

We are seeking an experienced Senior Quality Assurance Engineering Leader to join our team. In this role, you will be responsible for ensuring compliance with quality processes and regulations.

About Us:

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, critical care, and surgical monitoring.

Key Responsibilities:

  • Lead complex assessments, including audits, to ensure conformance with applicable regulations and policies.
  • Assess objective evidence to determine conformity to requirements.
  • Provide technical guidance and lead projects on quality initiatives, including designing and recommending systems.
  • Plan annual audit schedules, assign SMEs, establish audit content, allocate time, and schedule meetings.
  • Identify, lead, and implement business process improvement solutions for Quality Systems.
  • Support teams on system usage and process requirements.
  • Recommend changes to documentation associated with Quality Systems.
  • Train, coach, and guide lower-level employees on procedures.

Education and Experience:

Bachelor's degree in engineering or a scientific field, 6 years of experience minimum, including either industry or education required. Master's Degree or equivalent in Engineering or Scientific field, 5 years of experience minimum, including either industry or education required. Ph.D. or equivalent in Engineering or Scientific field, 2 years of experience minimum of experience, including either industry or education required.

Additional Skills:

Proven expertise in MS Office Suite and experience with quality systems (e.g., CAPA, Ignite). Experienced in GxP. Good project management skills and related software tools preferred. Excellent written and verbal communication skills, including influencing and relationship management skills. Strong problem-solving and critical thinking skills. Ability to read, comprehend, write, and speak English fluently, required. Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems. Excellent knowledge of medical or pharmaceutical regulations as relating to documentation. Excellent understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485, ISO14971, and MDD).

About Edwards Lifesciences:

Edwards Lifesciences is committed to helping patients by developing innovative medical technologies that improve their lives. We focus on creating new products and improving existing ones to address unmet healthcare needs. With extensive operations globally, we employ over 13,000 individuals worldwide who share our passion for making a difference in the lives of our patients.



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