Senior Quality Engineer: Drive Process Risk & Compliance

Integra LifeSciences; Massachusetts; On-site; USD 82,000 - 113,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) savings plan

Job summary

Integra LifeSciences seeks a Sr. Quality Engineer to drive quality improvements across the product lifecycle. You will lead risk-based analysis, CAPAs and supplier audits while mentoring engineers and technicians on quality systems and processes.

In this role you will analyze data for process improvements, oversee nonconformances, and ensure regulatory alignment with ISO-13485 and FDA standards. The position emphasizes manufacturing knowledge and cross-functional collaboration to safeguard

Qualifications

• Bachelor's degree or equivalent with 8+ years of experience, Master degree with 5+ years, Doctoral degree with 3+ years.
• Manufacturing/operations experience required.
• Strong knowledge of FDA and ISO product/process risk management and risk mitigation.
• Experience with CAPAs, NCs and internal/supplier audits.

Responsibilities

• Support quality improvement initiatives and process/product characterizations for cost improvements.
• Work on non-conforming reports: initiate, analysis, investigation, review and close.
• Collaborate with third-party suppliers to resolve NC issues.
• Conduct internal/supplier audits per ISO-13485 and/or 21 CFR 820.
• Develop and implement process monitoring methods aligned with risk.
• Collect data and perform statistical analyses for process improvements.
• Investigate and document nonconformances, CAPAs and customer complaints.
• Own material identification, segregation and defect classification in manufacturing.

Skills

Risk Management

Quality Engineering

Statistical Analysis

Root Cause Analysis

Manufacturing Knowledge

Education

Bachelor's degree or equivalent

Master's degree

Doctoral degree

Tools

ISO-13485

21 CFR 820

Job description

Integra LifeSciences seeks a Sr. Quality Engineer to drive quality improvements across the product lifecycle. You will lead risk-based analysis, CAPAs and supplier audits while mentoring engineers and technicians on quality systems and processes.

In this role you will analyze data for process improvements, oversee nonconformances, and ensure regulatory alignment with ISO-13485 and FDA standards. The position emphasizes manufacturing knowledge and cross-functional collaboration to safeguard