Sr. Quality Engineer

Top 5 Key Responsibilities

• Represent Quality in cross-functional projects, ensuring compliance with regulatory and internal quality standards.
• Support process verification and validation activities (IQ/OQ/PQ), including documentation and reporting.
• Collaborate in the development and update of manufacturing documentation, including procedures, work instructions, and risk management (e.g., FMEA).
• Analyze manufacturing issues and non-conformities to identify root causes and drive continuous improvement actions.
• Support supplier quality activities (audits, validations, changes) and participate in internal and external audits.

Requirements (Education & Experience)

• Fluent in English and Spanish (written and verbal).
• 5–10 years of experience in the medical device industry or other regulated environments.
• Bachelor’s degree in engineering or related...