Staff Software Quality Engineer, Post Market Integration

• 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.

• 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.

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.