About this opportunity
IntePros lists this Quality Engineer - Medical Device opportunity in bergen county, nj, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.