Staff Software Quality Engineer, Post Market Integration

Regulatory Toolkit; Flower Mound (TX); Hybrid; USD 113,000 - 188,000; Full time

Job summary

Stryker is hiring a Staff Software Quality Engineer, Post Market Integration for endoscopy and communications. You will lead as a quality engineering expert, driving investigations, CAPA, change management, and continuous improvements across the product lifecycle.

You will partner with R&D, Operations, Commercial, and Quality teams to ensure product reliability, patient safety, and regulatory compliance in a fast-paced, 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

• Lead 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 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 and driving continuous improvement opportunities.
• Analyze quality and operational performance metrics to identify trends 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.

Skills

Quality engineering

Root cause analysis

Risk management

CAPA processes

SDLC knowledge

Education

Bachelor's degree in Science or Engineering

Job description

Work Flexibility: Hybrid or Onsite

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.

What you need
Required

• 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

Travel Percentage: 30%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.