Upvote
Downvote
Quality Manager
Share Job
- Suggest Revision
$110,000 - $145,000 a year
Full-time
- This individual will serve as the Quality Subject Matter Expert (SME) and routinely report to Executive Management on the QMS health and compliance status.
- The essential responsibility of this role is to assure local & global compliance of the IRRAS Quality Management System (QMS) to all applicable regulatory standards and device & site registrations.
- The ideal candidate will have a deep understanding of the medical device industry as it pertains to managing and improving a medical device QMS. This person will own the QMS throughout the product life cycle, during agency audits, and the assure the IRRAS Class I measure & sterile, Class IIb electro-mechanical and sterile, and Class III sterile medical devices are held to the highest quality standards.
- Oversee all QMS activities, e.g., Training, Customer feedback & complaint management, Deviations, non-conformances, quarantine materials, Corrective and Preventive Actions (CAPAs), Supplier quality, Supplier Corrective Action Reports (SCARs), Change Control, Preventative Maintenance and Calibration, Product Recalls, QMS administration, etc.
- Continuously improve the QMS to remain in alignment with the ever-evolving business needs.
Active Job
Updated 15 days agoSimilar Job
Relevance
Active