Quality Engineer

Barrington James; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Barrington James is seeking an experienced Quality Engineer for a MedTech client in New Jersey. The role supports quality systems, design transfers, and regulatory compliance within cross-functional teams.

You will participate in audits, risk management, and process improvements, ensuring adherence to FDA QMSR, ISO 13485, and EU MDR across development and manufacturing activities.

Qualifications

• Bachelor's or advanced degree in a relevant field.
• 4+ years of experience in Quality Management for medical devices.
• Strong knowledge of FDA QMSR and ISO 13485 and EU MDR.
• Excellent written and verbal communication skills.

Responsibilities

• Support the maintenance and improvement of quality management processes to meet regulatory requirements.
• Work with cross-functional teams to maintain and improve product and process quality.
• Support regulatory audits and inspections.
• Assist with quality-related training activities.
• Support product development activities, including design reviews, testing, validation, and transfer to manufacturing.
• Help ensure compliance with applicable regulations and design control requirements.
• Support risk management and product safety activities.
• Assist with manufacturing quality, process controls, and change management.
• Support investigations into quality issues, root cause analysis, and corrective actions.

Skills

Communication skills

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Job description

My client is an innovative MedTech developing advanced technology for surgical applications. Due to continued growth across the US market, they are seeking an experienced Quality Engineer to join their collaborative multi-disciplinary team.

Responsibilities:

• Support the maintenance and improvement of quality management processes to meet regulatory requirements.
• Work with cross-functional teams to maintain and improve product and process quality.
• Support regulatory audits and inspections.
• Assist with quality-related training activities.
• Support product development activities, including design reviews, testing, validation, and transfer to manufacturing.
• Help ensure compliance with applicable regulations and design control requirements.
• Support risk management and product safety activities.
• Assist with manufacturing quality, process controls, and change management.
• Support investigations into quality issues, root cause analysis, and corrective actions.

Qualifications:

• Bachelors degree or advanced degree in relevant field.
• 4+ years of experience in the areas of Quality Management, for medical device.
• Strong knowledge of compliance with FDA QMSR and ISO 13485 and EUMDR.
• Excellent written and verbal communication skills.