Quality Engineer II — Medical Devices Innovator

Integra LifeSciences; Braintree (MA); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences is seeking a Quality Engineer II to support manufacturing and engineering operations in ensuring safe, compliant, and high-quality medical devices.

The role involves owning investigations, CAPAs, risk management, and validation support, with increasing technical depth and cross‑functional collaboration across Manufacturing, Engineering, Regulatory Affairs, and Supply Chain. On-site position in the United States.

Qualifications

• Bachelor's degree in Engineering or Life Science or related field.
• 3+ years of Quality Engineering in a regulated manufacturing environment (or 1–2 years with a Master’s).
• Medical device industry experience and knowledge of FDA/ISO quality standards.

Responsibilities

• Own investigations, CAPAs, nonconformances, and deviations.
• Lead/assist validation activities for processes, tests, and equipment.
• Contribute to risk management, pFMEA, and quality systems improvements.
• Support NPI and product transfers from a quality engineering perspective.
• Prepare quality data and metrics for management review.

Skills

Quality engineering

Regulatory knowledge

Problem solving

Communication skills

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in Engineering or Life Science

Tools

Minitab

SPC

TrackWise Digital

QMS software

ERP systems

Job description

Integra LifeSciences is seeking a Quality Engineer II to support manufacturing and engineering operations in ensuring safe, compliant, and high-quality medical devices.

The role involves owning investigations, CAPAs, risk management, and validation support, with increasing technical depth and cross‑functional collaboration across Manufacturing, Engineering, Regulatory Affairs, and Supply Chain. On-site position in the United States.