Quality Engineer – Medical Devices (Level 3)

About the role

The Quality Engineer 3 will provide engineering support for the development and production of Class I‑III medical devices at Viant’s Heredia site. The role involves quality planning, process validation, risk analysis, and supplier quality management while collaborating with cross‑functional teams.

Key responsibilities

• Coordinate new process inspections and interface with design, production, and external vendors.
• Prepare and execute qualification and validation activities (IQ, OQ, PQ) in compliance with FDA regulations.
• Lead investigations for audit non‑conformances, complaints, and CAPA initiatives.
• Develop risk management documentation such as Risk Management Plans, Reports, and Process FMEAs.
• Supervise Quality Inspectors/Technicians, assign tasks, and provide training.
• Act as an internal auditor and support external supplier audits and vendor qualification.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics, Chemistry or related field.
• Advanced bilingual English/Spanish communication skills.
• Minimum 2 years experience in a regulated manufacturing environment (medical devices, pharma, aerospace, etc.).
• Knowledge of FDA, ISO and other medical‑device regulations.
• Experience with risk management (PFMEA) and process validation.

Required skills

• Minitab statistical software
• Six Sigma methodology and Lean Manufacturing
• MS Project
• Statistical techniques (Sampling Plans, Gage R&R, SPC, DOE)
• Process validation and software validation
• Risk management (PFMEA) and root‑cause analysis tools
• Regulatory knowledge (FDA, ISO)