Design Assurance Quality Engineer

Masimo; Mexicali; Presencial; MXN 859.402 - 1.203.162; Jornada completa

Descripción de la vacante

Masimo is looking for a Quality Assurance Engineer in Mexicali, Baja California. This role involves providing escalation support for quality issues and ensuring compliance with ISO 13485 standards. You will collaborate with R&D and support design controls while maintaining audit-ready documentation.

The ideal candidate holds an A/BS Degree and has over 3 years of experience in the medical device industry. Strong communication and organizational skills are essential for this position.

Formación

• 3+ years of experience in quality engineering within the medical device industry.
• Hands-on experience in implementing quality systems per ISO 13485.
• Ability to work effectively in a project team environment.

Responsabilidades

• Provide escalation support for significant quality issues.
• Partner with R&D on quality and manufacturability for new products.
• Support verification & validation activities with production-representative builds.

Conocimientos

Design Assurance Quality Engineering

Product Quality

Manufacturing Quality

Excellent verbal and written communication

Excellent prioritizing and organizational skills

Educación

A/BS Degree or equivalent in a technical discipline

Descripción del empleo

Responsibilities

• Provide escalation support for significant quality issues
• Ensure timely assessment and containment of quality event
• Partner with R&D to embed quality and manufacturability into new product designs
• Support design controls for development and sustaining changes
• Participate in design reviews with a strong focus on producibility and risk
• Ensure design changes are manufacturable, verifiable, and compliant
• Support verification & validation activities with production-representative builds
• Support risk management (DFMEA, use-related risk, production risk inputs)
• Investigate design-related production issues and quality escapes
• Translate production floor feedback into actionable R&D design improvements
• Ensure design documentation and traceability (DHF, requirements, V&V) are audit-ready
• Support audits and inspections related to design controls
• Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
• 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)
• Collaborate with Supplier Quality and Supply Chain leadership on supplier-related quality issues

Qualifications

• A/BS Degree, or equivalent combination of education and experience in a technical discipline is required
• 3+ years of experience in Design Assurance Quality Engineering, Product Quality, or Manufacturing Quality in medical device industry
• Must have working knowledge of quality systems and practices
• Must be able to provide guidance to functional teams on quality requirements
• Experience in Quality Systems per ISO 13485
• Ability to work in a Project Team Environment
• Direct experience supporting manufacturing of regulated medical products
• Strong working knowledge of CAPA, nonconformance management, change control, and root cause analysis
• Excellent verbal and written communication skills
• Excellent prioritizing, organizational, and interpersonal skills
• Excellent documentation skills including detail-oriented, record maintenance/tracking and understanding of document traceability