Quality Engineer - Medical Device

Quality Engineer – Medical Device

Location: Mahwah, NJ | Hybrid, 3 days/week

Employment Type: Initial 12-month contract, with potential for extension or conversion to a permanent role

Position Overview

A leading medical device manufacturer is seeking a Quality Engineer to support new product transfer and manufacturing implementation activities. This role will partner with Quality, Design Engineering, Manufacturing Engineering, and suppliers to ensure products and processes meet quality standards and regulatory requirements throughout the transition to production.

Key Responsibilities

• Support quality planning, change control, risk management, and continuous improvement activities.
• Review and support equipment qualification, process validation, and First Article Inspection (FAI) documentation.
• Assist with the development and maintenance of SOPs, quality records, and controlled documentation.
• Support root cause investigations, corrective actions, and process improvement initiatives.
• Collaborate cross-functionally to ensure manufacturing processes meet quality and regulatory requirements.
• Track quality deliverables and communicate project status, risks, and issues to stakeholders.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Approximately 1–3 years of Quality Engineering, Manufacturing Engineering, or related experience; equivalent relevant experience will be considered.
• Medical device, pharmaceutical, or other regulated industry experience preferred.
• Familiarity with quality management systems, change control, risk management, and process validation.
• Knowledge of ISO 13485, GMP, GDP, or similar regulatory standards is a plus.
• Strong analytical, documentation, communication, and problem-solving skills.

This is an initial 12-month assignment with the potential for extension or conversion to a permanent position.