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Joint Replacement is hiring a Senior QMS Specialist, Field Quality (Remote)! In this role, you will play a pivotal role in developing and maintaining the quality management system to ensure compliance with all relevant regulatory requirements for medical devices.
Our Field Quality Teams support US branches in temperature monitoring, torque calibration devices, cycle counting, internal/external audits, document control and NC/CAPA management. You’ll drive compliance and promote best practices across the US Field, ensuring consistent and high-quality standards!
What you will do:
You will oversee, support, and ensure that an effective and efficient quality management system is built and maintained
You will assist in driving and providing oversight of QMS elements for US Field Operations
You will support QMS compliance with relevant internal and external regulatory requirements
You will participate in developing an optimized future state of the QMS to align with business needs
You will identify and implement improvement opportunities to increase QMS efficiency and effectiveness
You will support the development and delivery of QMS training
You will contribute to the creation, maintenance, and improvement of QMS policies and procedures
You will support internal and external quality system audits
You will manage field-related NCs and CAPAs, including ownership and documentation.
What you need:
Required:
Bachelor’s degree preferred; in lieu of degree equivalent experience will be considered.
2+ years relevant working experience required.
Experience in a regulated environment, including interaction with regulatory agencies. Preferably in the medical device sector.
Preferred:
ERP system experience (e.g., Oracle, SAP)
OnePLM experience
WebOps experience
NC/CAPA (Nonconformance and Corrective Action/Preventive Action) experience
Quality Systems experience
Strong influencing skills with the ability to gain alignment for strategic field operations initiatives
Ability to obtain AATB (American Association of Tissue Banks) certification within 3 months of hire
Experience leading complex, transformational initiatives in inventory management, quality, auditing, or operations
Demonstrated ability to apply technical applications to improve business processes
Other:
Travel will range from 20-30%
$67,400- $136,200 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.