Senior Quality Engineer I

Integra LifeSciences•US-PR-Anasco-165-Facility, PR

2d•$51,000 - $71,000•Hybrid

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer is responsible for ensuring the manufacture of safe, compliant, and high-quality medical devices by maintaining effective quality systems, supporting manufacturing and engineering operations, and driving continuous quality improvement. They plan and execute of their duties in compliance with site and enterprise procedures, corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. These positions operate with increasing independence, technical depth, and leadership responsibility commensurate with level assignment.

Requirements

Bachelor’s degree in engineering or science
5–8+ years Quality Engineering experience

Nice To Haves

ASQ CQE or Lean Six Sigma preferred

Responsibilities

Ensure compliance with FDA QSR, ISO 13485, ISO 9001, MDR, CMDR, and internal quality system procedures.
Review, approve, and support quality records including nonconformances, investigations, CAPAs, change controls, validations, and risk documentation.
Provide quality engineering support to manufacturing operations, including inspections and data analysis.
Participate in internal and external audits including FDA inspections and ISO surveillance audits.
Apply statistical and risk-based tools such as SPC, FMEA, and sampling plans.
Support complaint investigations, KPI monitoring, and SPC trending to drive product and process improvements.
Collaborate cross-functionally with Manufacturing, Engineering, Regulatory, and Supply Chain.
Support Quality Management Reviews and performance metrics.
Lead complex investigations, CAPAs, and cross-functional quality initiatives.
Serve as subject matter expert for assigned products, processes, or quality systems.
Approve high-impact validations, change controls, and risk documentation.
Drive continuous improvement initiatives using Lean, Six Sigma, and advanced statistical methods.
Provide guidance and mentoring to junior Quality Engineers.