MANAGER, SUSTAINING QUALITY ASSURANCE ENGINEERING

Masimo

Full-time baja california, baja california Other-General

Posted:

March 01, 2026

Location:

baja california, baja california, Mexico

Job Description

                    Responsibilities Provide escalation support for significant quality issues 
Ensure timely assessment and containment of quality event 
Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material 
Own and oversee quality input to post-release design and process changes (ECOs, deviations, waivers, temporary changes) 
Ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements 
Ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented 
Ensure sustained compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1) 
Collaborating with Supplier Quality and Supply Chain leadership on supplier-related quality issues 

            

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Job Overview

Job Type: Full-time

Location: baja california, Mexico

Posted: March 01, 2026

Deadline: April 10, 2026