Staff Software Quality Engineer, Post Market Integration
Stryker
Summary
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.
Job description
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.
Requirements
- 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
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.