Projects & Validations Quality Engineer II

About the role

The Projects & Validations Quality Engineer II ensures and expands quality assurance by improving existing processes and creating new ones. This role translates regulatory, quality system and customer requirements into actionable project plans and supports design transfer to manufacturing.

Key responsibilities

• Develop and oversee validation strategies for manufacturing processes, equipment, test methods and computerized systems.
• Translate regulatory and customer requirements into quality plans, review designs, and manage design changes.
• Assess supplier and outsourced‑process quality risks, coordinate qualifications and change reviews.
• Review and approve controlled documents such as specifications, protocols, reports and device history records.
• Analyze verification, validation, production and complaint data; lead investigations of deviations and non‑conformances.

Required profile

• Bachelor’s degree in an engineering discipline.
• 3‑5 years of quality experience supporting manufacturing lines, with at least 3 years in the medical‑device industry (preferred).
• Advanced bilingual proficiency in English and Spanish.
• Strong analytical abilities demonstrated through statistical analysis using Minitab.
• Experience leading multidisciplinary teams and communicating with internal and external stakeholders.

Required skills

• Minitab for statistical analysis.
• Root cause analysis and CAPA implementation.
• Validation documentation (IQ, OQ, PQ, TMV) and data analysis.
• Lean Six Sigma methodology (Green Belt preferred).
• ISO 13485 auditor knowledge.
• Design of Experiments (DOE), Statistical Process Control (SPC), ANOVA.