Sr. Quality Management System Specialist
$72.5k - $120.9kStryker Orthopaedics
Senior Quality Management System Specialist will design, maintain, and improve a quality management system supporting regulatory approval and business growth across global markets. The role involves collaborating across functions to ensure quality processes are compliant, practical, and scalable in a hybrid position in Portage, Michigan.
Responsibilities
- Support and maintain a compliant quality management system aligned with medical device regulations
- Develop and update quality system processes, procedures, and documentation
- Assess quality system requirements to optimize structure, integration, and scalability
- Identify and implement continuous improvement opportunities in quality processes
- Prepare for and support internal, external, and third-party quality system audits
Requirements
- Bachelor's degree in science, engineering, business, or related field
- 3+ years of experience in regulated industry environments
- Knowledge of U.S. and international medical device regulatory requirements
- Experience supporting quality system activities such as audits and management review
- Familiarity with regulated information systems or quality systems change control
- Exposure to good manufacturing and distribution practices
Compensation: $72,500-$120,900 USD annual
Vacancy posted 11 days ago
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