Staff Software Quality Engineer, Post Market Integration

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.

$112900 - $188100 USD Annual