Quality & Reliability Engineer II

About the role

We are looking for a Quality & Reliability Engineer II to support product quality in a manufacturing environment. The role involves applying engineering and statistical techniques to resolve quality issues, validate processes, and ensure compliance with regulatory standards.

Key responsibilities

• Validate new equipment, products, and processes using IQ, OQ, PQ, SQ, TVM and FMEA protocols.
• Prepare, execute and analyse data for validation activities and generate detailed reports.
• Investigate customer, supplier and internal non‑conformance complaints, perform root‑cause analysis and implement corrective actions.
• Develop and maintain technical procedures, work instructions and quality metrics.
• Train operators and engineers on validation and quality procedures.
• Approve customer drawings for manufacturing and ensure compliance with ISO 13485 and FDA regulations.
• Conduct internal audits and serve as liaison with external customers.
• Supervise Quality Engineers I and support continuous improvement initiatives.

Required profile

• 1‑2 years of experience as a Quality Engineer or similar role in a manufacturing setting.
• Bachelor’s degree in engineering, science or a related field.
• Bilingual English (intermediate) and Spanish.
• Ability to work independently with minimal supervision.
• Strong written communication skills for technical reports.

Required skills

• Minitab and JMP for statistical analysis.
• Knowledge of ISO 13485, FDA regulations and validation protocols (IQ, OQ, PQ, SQ, TVM).
• FMEA methodology.
• Microsoft Office suite.
• Experience with inventory and manufacturing software, spreadsheets and word processors.