Quality Engineer II — Med Device Quality & Compliance

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid time off

Job summary

Integra LifeSciences in Massachusetts is seeking a Quality Engineer II to independently support manufacturing and engineering operations. The role ensures safe, compliant medical devices by owning investigations, CAPAs, risk management, and validation activities within cGMP and regulatory frameworks.

The position emphasizes data-driven quality improvements, DOEs, MRB coordination, and cross‑functional collaboration to support NPI, transfers, and regulatory submissions. On-site work required.

Qualifications

• Bachelor's degree in Engineering or Life Science.
• Minimum 3 years of Quality Engineering in a regulated setting.
• Experience with FDA/ISO quality standards in medical devices.
• Experience owning nonconformances, investigations, and CAPAs.
• Knowledge of QMS, ERP, and data systems.

Responsibilities

• Own investigations, NCs, and CAPAs; perform root cause analysis and effectiveness checks.
• Lead or support validation activities for processes, tests, and equipment.
• Conduct or support audits and regulatory inspections (FDA/ISO).
• Develop DOEs and statistically sound tests to support results.
• Collaborate with Manufacturing, Engineering, Regulatory, and Supply Chain.

Skills

Quality Engineering

FDA QSR

CAPA management

Risk management

Statistical analysis

Minitab

ERP systems

SQA documentation

Education

Bachelor's degree in Engineering/Life Science

Tools

TrackWise

ERP systems

Minitab

Databases

Job description

Integra LifeSciences in Massachusetts is seeking a Quality Engineer II to independently support manufacturing and engineering operations. The role ensures safe, compliant medical devices by owning investigations, CAPAs, risk management, and validation activities within cGMP and regulatory frameworks.

The position emphasizes data-driven quality improvements, DOEs, MRB coordination, and cross‑functional collaboration to support NPI, transfers, and regulatory submissions. On-site work required.