Staff Software Quality Engineer, Post Market Integration

Role overview

Responsibilities

• Lead complex investigations, root cause analysis, risk management, customer complaints, nonconformance, CAPA, and field actions.
• Partner with customers and cross-functional teams to resolve product and process quality issues.
• Review change management, design, and development activities and identify improvement opportunities.
• Use quality and operational metrics to improve product quality, reliability, and compliance.
• Apply human factors, statistical methods, and quality engineering across development, validation, usability, and lifecycle management.
• Improve manufacturing processes and quality systems; support audits and regulatory inspections.
• Serve as a technical resource and mentor.

Required qualifications

• Bachelor’s degree in science, engineering, or a related discipline.
• At least four years of experience in a regulated and/or technology-driven industry.
• Proficiency in SDLC processes and methodologies.
• Strong quality-concept knowledge, including risk management, CAPA, audits, and statistics.
• Able to work in clinical environments, interact with healthcare professionals, and observe live and simulated procedures.
• Able to obtain and maintain facility-access credentials, including applicable health screenings, vaccinations, and background checks.

Preferred qualifications

• Medical device industry experience and knowledge of U.S. and international regulations, standards, ISO 13485, GDP, and GMP.
• Working knowledge of computer hardware and related technologies.

Compensation

• Annual salary range: $112,900–$188,100 USD.

Benefits

• Benefits include medical, prescription, dental, vision, critical illness, accident, hospital indemnity, and disability coverage; wellness support; HSA and FSA; 401(k); and employee stock purchase plan.

About Stryker