Quality Engineer

Job Title:

Quality Engineer – Medical Devices (Mid-Level)

We are seeking a mid-level Quality Engineer to support the Quality Management System (QMS) and ensure compliance with FDA and ISO requirements across the medical device product lifecycle, including design, manufacturing, and post‑market activities.

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulations
• Support design controls, risk management (ISO 14971), and verification/validation activities
• Manage CAPA, nonconformances, root cause analysis, and effectiveness checks
• Support internal and external audits and related responses
• Review and approve quality documentation and change controls
• Support supplier quality activities and continuous improvement initiatives
• Collaborate cross‑functionally with R&D, Manufacturing, Regulatory, and Operations

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3–6 years of quality engineering experience in medical devices
• Knowledge of FDA QSR, ISO 13485, CAPA, and design controls
• Strong communication, documentation, and problem‑solving skills

• Audit support experience (FDA/ISO)
• Knowledge of SPC, MSA, FMEA, or supplier quality