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Website: stryker.com
The Stryker is a family of eight-wheeled armored fighting vehicles derived from the Canadian LAV III, which in turn derived from the Swiss Mowag Piranha. Stryker vehicles are produced by General Dynamics Land Systems-Canada (GDLS-C) for the United States Army in a plant in London, Ontario. It has four-wheel drive (8×4) and can be switched to all-wheel drive (8×8).
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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,…
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