Medical Device Process Validation Specialist

hace 1 mes


Tijuana, Baja California, México Outset Medical A tiempo completo
Quality Engineer

We are seeking a highly skilled Quality Engineer to join our team at Outset Medical. In this role, you will play a critical part in ensuring the quality of our innovative medical devices.

Estimated Salary: $85,000 - $110,000 per year

About the Job

This is a challenging and rewarding opportunity for an experienced Quality Engineer to lead process validation strategies, non-conformances, MRB, CAPA's, and data analysis. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards.

The successful candidate will have a strong understanding of medical device regulations and standards, including 21 CFR 820, GMP, EN ISO 13485, and ISO 14971. You will be responsible for developing and executing transfer validation strategies, analyzing failure analysis, and leading implementation of assurances and process controls.

You will also be expected to prepare monthly quality trend analysis and reports, lead coaching and mentoring of non-exempt and entry-level exempt personnel, and possess excellent interpersonal and analytical skills.

Requirements and Qualifications
  • Bachelor's degree in engineering or technical field or equivalent experience
  • Minimum of 3-5 years of experience in medical device industry
  • Knowledge of medical device regulations and standards
  • Excellent communication and analytical skills
  • Ability to read and understand technical data
About Outset Medical

At Outset Medical, we believe in creating a revolution in the medical device industry by innovating everywhere with intelligent speed. We strive to give patients and providers the power to take control of their lives by pioneering groundbreaking technology that redefines the landscape of dialysis.

We offer a dynamic and collaborative work environment, where every person matters. Our team is passionate about making a difference, and we expect nothing less than our best display of strengths and skills. If you share our passion for innovation and excellence, we encourage you to apply for this exciting opportunity.



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