Quality Engineer II — Medical Devices & CAPA Lead

Integra LifeSciences Corporation; Braintree, Northern (MA, KY); Hybrid; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Job summary

Integra LifeSciences Corporation is hiring a Quality Engineer II to support manufacturing and engineering operations at our on-site Massachusetts facility. You will own investigations, CAPAs, and risk management while ensuring compliance with FDA QSR, ISO 13485, and cGMP requirements.

You will collaborate with cross-functional teams to drive process improvements, validation activities, and supplier audits, ensuring high-quality medical devices and robust quality systems across the organization.

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Chemical, Electrical) or Life Science field.
• Minimum 3 years of Quality Engineering experience in a regulated manufacturing environment (or 1-2 years with a Master's).
• Medical device industry experience and familiarity with FDA/ISO quality standards.
• Experience owning nonconformances, investigations, CAPAs, and change controls.
• Proficiency with QMS, ERP systems, and data analysis tools (SPC/Minitab) and strong communication.

Responsibilities

• Own investigations, nonconformances, CAPAs and risk management activities.
• Lead or support validation, DOEs, and statistical testing for processes.
• Collaborate with Manufacturing, Engineering, Regulatory, and Supply Chain teams.
• Support NPI and product transfers as Quality Engineering representative.
• Prepare quality data and metrics for management review.
• Assist in internal and regulatory audits and supplier assessments.

Skills

Quality engineering

Root cause analysis

Data analysis

Cross-functional collaboration

Documentation

Statistical thinking

Communication

Education

Bachelor's degree in Engineering or Life Sciences

Tools

QMS

ERP systems

Minitab

DOE methods

MS Office

Job description

Integra LifeSciences Corporation is hiring a Quality Engineer II to support manufacturing and engineering operations at our on-site Massachusetts facility. You will own investigations, CAPAs, and risk management while ensuring compliance with FDA QSR, ISO 13485, and cGMP requirements.

You will collaborate with cross-functional teams to drive process improvements, validation activities, and supplier audits, ensuring high-quality medical devices and robust quality systems across the organization.