Staff Software Quality Engineer, Post Market Integration

Stryker; Flower Mound (TX); On-site; USD 113,000 - 188,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker is hiring a Staff Software Quality Engineer for Post Market Integration in endoscopy and communications. You will lead quality investigations, CAPA, and risk management across the product lifecycle to ensure patient safety and regulatory compliance.

In this highly visible role, you will partner with R&D, Operations, Commercial, and Quality teams to drive continuous improvement, support audits, and mentor teams on software quality and SDLC best practices within a regulated environment.

Qualifications

• Bachelor's degree in a Science, Engineering or related discipline.
• Minimum of 4 years of experience in a regulated and/or technology-driven industry.
• Proficiency in Software Development Lifecycle (SDLC) processes and methodologies.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including health screenings, vaccinations, and background checks.

Responsibilities

• Serve as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.
• Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.
• Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.
• Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.
• Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.
• Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.
• Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.
• Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.

Skills

SDLC knowledge

Quality concepts

Root cause analysis

Education

Bachelor's degree in Science/Engineering or related discipline

Job description

Stryker is hiring a Staff Software Quality Engineer, Post Market Integration endoscopy and communications business. In this highly visible role, you will serve as a quality engineering leader for commercialized products, driving complex investigations, risk management activities, product quality improvements, and regulatory compliance across the product lifecycle. Partnering closely with R&D, Operations, Commercial, and Quality teams, you will lead customer complaint investigations, CAPA, change management reviews, and continuous improvement initiatives while leveraging software quality, SDLC, and quality system expertise to enhance product reliability, performance, and patient safety. This role is ideal for an experienced quality professional who thrives in a fast-paced, regulated environment and enjoys solving complex technical challenges that directly impact customers and healthcare outcomes.

What You Will Do

• Serve as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.
• Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.
• Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.
• Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.
• Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.
• Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.
• Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.
• Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.

Required

What you need

• Bachelors degree in a Science, Engineering or related discipline
• Minimum of 4 years of experience in a regulated and/or technology-driven industry.
• Proficiency in Software Development Lifecycle (SDLC) processes and methodologies.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including applicable health screenings, vaccinations, and background checks.

Preferred

• Experience working within the medical device industry, including knowledge of U.S. and international medical device regulations, standards, and quality systems such as ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Working knowledge of computer hardware and related technologies.

$112,900 - $188,100 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.