Quality Systems Specialist

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified checked Jun 13, 2026

Salary

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401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Schedule

Shift type

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Weekend work

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Application

Cover letter

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Assessment

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Deadline

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Where they hire

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About this role

Quality Systems Specialist Tijuana, Mexico Company Overview Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day. At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love. Position Overview The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS).This role supports quality system processes including document control, training, change control nonconformance, and CAPA activities. The specialist monitors quality metrics, assists with audits, and ensures compliance with applicable global regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820. Essential Job Functions and Responsibilities · Support monitoring and continuous improvement of Quality Management System processes. ·

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