Senior Staff Specialist, Quality eSystems

Stryker is seeking a Senior Staff Specialist, Quality eSystems in Kalamazoo, Michigan to lead quality systems and electronic data management initiatives that directly support our medical device manufacturing and regulatory compliance excellence.

The Opportunity

Join Stryker as a Senior Staff Specialist, Quality eSystems where you'll own strategic responsibility for the design, implementation, and continuous improvement of electronic quality management systems. This is a full-time position based in Kalamazoo, offering the chance to shape how quality data and systems infrastructure support one of the world's leading medical technology companies. You'll work at the intersection of quality assurance, regulatory affairs, and technology, driving organizational capability and compliance across a global enterprise.

Your Responsibilities

• Architect and oversee enterprise quality management systems (QMS) and eSystems platforms, ensuring robust electronic data capture, management, and reporting
• Partner with quality assurance, regulatory, manufacturing, and IT teams to define system requirements, validate solutions, and maintain regulatory compliance
• Lead the evaluation, selection, and implementation of quality systems software and tools that enhance operational efficiency and regulatory readiness
• Develop and maintain electronic record strategies, validation protocols, and audit procedures aligned with FDA, ISO, and internal quality standards
• Mentor junior specialists and cross-functional teams on quality systems best practices, data governance, and eSystems technologies
• Monitor industry trends, regulatory changes, and emerging systems technologies to recommend continuous process and capability improvements

Qualifications

• Bachelor's degree in engineering, computer science, quality management, or related discipline
• Minimum 8+ years of professional experience in quality systems, systems engineering, or manufacturing quality roles, preferably in medical devices or regulated industries
• Demonstrated expertise with enterprise quality management systems, ERP platforms, and electronic data management solutions
• Strong understanding of FDA regulations (21 CFR Part 11, Part 820), ISO 13485, and international quality standards
• Proven ability to lead cross-functional projects, influence stakeholders, and drive organizational change
• Excellent technical communication skills and ability to translate between quality, regulatory, and IT perspectives
• Advanced proficiency in data analysis, process mapping, and systems validation methodologies

About Stryker

Stryker is a leading global medical technology company headquartered in Kalamazoo, Michigan, with a mission to make healthcare better. We innovate across orthopedics, medical and surgical, neurotechnology, and spine solutions, serving healthcare systems, surgical facilities, and patients worldwide. Our commitment to quality, safety, and regulatory excellence drives everything we do, and we're seeking talented professionals who share our dedication to advancing patient outcomes and surgeon performance.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.