Senior Principal Specialist, QMS
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AI Summary
Lead the strategic development, governance, and continuous improvement of global electronic Quality Management Systems (QMS). Partner with cross-functional teams to ensure systems are scalable, compliant, and aligned with business needs.
Work Flexibility: Not available
The Senior Principal Specialist, Quality eSystems is responsible for strategic leadership in development, governance, and continuous improvement of global Quality Management System (QMS) electronic systems that support regulatory compliance and business operations. This role partners with Quality, Regulatory Affairs, Enterprise Digital Technologies (EDT), Global Process Owners, and cross-functional stakeholders to ensure enterprise systems are effective, scalable, compliant, and aligned with current and future business needs.
What You Will Do
- Lead the strategic development, implementation, and continuous improvement of global QMS electronic systems.
- Partner with Quality, Regulatory Affairs, and Enterprise Digital Technologies teams to implement system enhancements and new functionality.
- Collaborate with enterprise system teams to identify and resolve process gaps, redundancies, and integration challenges across platforms.
- Ensure system interfaces, dependencies, and data flows are documented, monitored, and escalated when issues arise.
- Drive enterprise system improvement initiatives that increase operational efficiency, compliance, and user effectiveness.
- Manage enterprise system activities to support project milestones, validation requirements, and business objectives.
- Provide regulatory and quality systems expertise during internal audits, external inspections, and compliance assessments.
- Develop and deliver eSystem governance, training, metrics, and reporting to support global adoption and GxP compliance.
What You Need
- Bachelor's degree in Science, Engineering, Business, or a related discipline.
- Minimum 10 years of experience working with enterprise Quality Management Systems (QMS) or electronic systems.
- Experience working in a regulated medical device, pharmaceutical, biotechnology, or related industry.
- Experience leading cross-functional and multi-site system implementations or improvement projects.
- Knowledge of U.S. and international medical device regulations and quality system requirements.
- Experience supporting system validation activities and compliance documentation within a regulated environment.
- Experience with enterprise system integration, governance, and lifecycle management.
- Experience conducting or supporting internal and external quality audits.
Preferred Qualifications
- Experience supporting global Quality Management System platforms.
- Experience partnering with Enterprise Digital Technologies or Information Technology organizations.
- Experience leading large-scale enterprise transformation initiatives across multiple geographies.
- Experience with robotic automation, AI and/or machine learning.
- Project management certification or formal project management experience.
- Experience developing quality metrics, dashboards, and performance reporting.
- Experience supporting system training and change management initiatives.
- Knowledge of GxP requirements and computerized system compliance.
- Experience working with global stakeholders across multiple time zones.
United States of America Pay Ranges:
- USN: $118,000 - $196,700 USD Annual
- US5: $123,900 - $206,500 USD Annual
- US10: $129,800 - $216,400 USD Annual
- US15: $135,700 - $226,200 USD Annual
- US20: $141,600 - $236,000 USD Annual
- US30: $153,400 - $255,700 USD Annual
Travel Percentage: NoneStryker 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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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