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Sr. Engineer, Software Quality

A healthcare company focused on saving and sustaining lives through medical device and pharmaceutical solutions since 1931.
91000 Bajos de Haina, Dominican Republic
Senior Software Engineer
In-Person
5,000+ Employees
5+ years of experience
Healthcare · Enterprise SaaS

Job Description

Baxter Healthcare, a leading healthcare company established in 1931, is seeking a Senior Software Quality Engineer to join their team in Haina, San Cristóbal. This role represents a unique opportunity to contribute to life-saving medical technologies while ensuring the highest standards of software quality and compliance.

The position combines technical expertise in software validation with quality assurance in a regulated medical device environment. You'll be responsible for conducting software audits, validating hardware and software inventory control, and ensuring compliance with FDA, GMP, and ISO requirements. This role is crucial in maintaining the company's high standards for medical device software quality.

As a Sr. Engineer in Software Quality, you'll collaborate with cross-functional teams, lead quality initiatives, and play a vital role in process improvement and software validation protocols. The ideal candidate brings 5+ years of experience in medical device or pharmaceutical industries, strong technical knowledge, and bilingual proficiency in English and Spanish.

This role offers the opportunity to work with a global healthcare leader committed to saving and sustaining lives. You'll be part of a mission-driven organization that values courage, trust, and collaboration, while working on technologies that directly impact patient care and safety. The position combines technical leadership with quality assurance expertise, making it ideal for professionals seeking to advance their careers in medical device software quality engineering.

Working at Baxter means joining a company with a strong sense of purpose, where your work directly contributes to improving healthcare outcomes worldwide. The role offers the chance to work with cutting-edge medical technologies while ensuring their safety and reliability through robust quality processes.

Last updated 7 days ago

Responsibilities For Sr. Engineer, Software Quality

  • Conduct periodical audits for software validations compliance
  • Validate hardware and software inventory control
  • Support Process Transfer activities including software validation
  • Lead POMs initiatives
  • Collaborate with teams to implement new processes and equipment
  • Perform Software Validations and Protocols of equipment and database applications
  • Facilitate long-term Quality Programs
  • Ensure compliance with GMP, FDA, ISO requirements
  • Support design and improvement of new product processes
  • Evaluate customer complaints and implement Corrective Actions
  • Develop Quality Sampling Plans

Requirements For Sr. Engineer, Software Quality

  • Bachelor's Degree in Engineering (Software or Industrial preferred)
  • 5+ years of experience in Medical Device or Pharmaceutical industries
  • Proficiency in Microsoft Office Software
  • Knowledge of Infrastructure Technology concepts
  • Database concepts expertise
  • Strong interpersonal skills
  • Knowledge of FDA, ISO, GAMP practices
  • Understanding of OSHA Regulations
  • Software Development Life Cycle knowledge
  • Fully bilingual (English and Spanish)

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