Staff Software Quality Engineer - Post-Market Hybrid/Remote

Stryker Corporation; Flower Mound (TX); Hybrid; USD 113,000 - 188,000; Full time

Job summary

Stryker Corporation is seeking a Staff Software Quality Engineer, Post Market Integration for the endoscopy and communications division. You will lead quality engineering investigations, risk management, and CAPA across the product lifecycle, partnering with R&D, Operations, and Commercial teams to improve product reliability, patient safety, and regulatory compliance.

The role requires a Bachelor’s degree in a science/engineering field, 4+ years in a regulated tech environment, and strong SDLC

Qualifications

• Bachelor's degree in Science, Engineering or related discipline.
• Minimum of 4 years in a regulated/technology-driven industry.
• Proficiency in Software Development Lifecycle (SDLC).
• Strong knowledge of Quality Concepts (Risk Management, CAPA, Audits, Statistics).
• Ability to work in hospital/clinical environments and obtain facility credentials.
• Med device experience and ISO 13485/GDP/GMP knowledge preferred.

Responsibilities

• Lead quality engineering investigations, root cause analysis and risk management across product lifecycle.
• Oversee customer complaint investigations, CAPA, field actions and regulatory quality processes.
• Collaborate with R&D, Operations, Commercial and QA to drive quality improvements.
• Influence change management and development activities by identifying risks and driving improvements.
• Analyze quality metrics to identify trends and improve product reliability and safety.
• Support audits and regulatory inspections as a technical resource and mentor.

Skills

SDLC processes

Quality concepts

Risk management

CAPA

Audits

Statistics

Cross-functional

Education

Bachelor's degree

Job description

Stryker Corporation is seeking a Staff Software Quality Engineer, Post Market Integration for the endoscopy and communications division. You will lead quality engineering investigations, risk management, and CAPA across the product lifecycle, partnering with R&D, Operations, and Commercial teams to improve product reliability, patient safety, and regulatory compliance.

The role requires a Bachelor’s degree in a science/engineering field, 4+ years in a regulated tech environment, and strong SDLC