Quality Specialist

The Job:
The Quality Specialist is responsible for a variety of duties within the Quality team and plays a critical role in the reliable execution of TJO’s Quality Management System. They will demonstrate an exceptional level of attention to detail and will collaborate with a broad cross-functional team within TJO: Document Control, Regulatory, Operations, Engineering, and Warehouse Staff. Additionally, the Quality Specialist will engage with our Instrument, Implant, and Packaging Suppliers on a routine basis as part of our supplier evaluation process and to ensure documentation, nonconformances, and corrective actions are addressed and closed out appropriately. They will primarily focus on consistent execution of our quality control activities to support the reliable and methodical release of implants and instruments.

The Basics:

• Create LHR’s, receive and verify certs, and perform required visual inspections as necessary
• Perform Quality activities for product release of production lots
• Review and disposition nonconforming product and work with our contract manufacturers to resolve any identified quality issues
• Review First Article data from suppliers for approval of initial production for new parts or new suppliers
• Assist in complaint investigations
• Assist in standard operating procedure and standard work development and lead process improvement projects
• Perform initial qualification, re-evaluation, and quality system audits of contract manufacturers
• Identify issues requiring corrective/preventive action. Perform investigation to determine root cause, implement corrective/preventive actions, and verify effectiveness of actions taken.
• Initiate, review, and approve engineering change orders for written procedures and product specifications
• Provide training for Quality processes to new or existing employees
• Assist with internal and external audits
• Perform other related assigned duties

Requirements

• Bachelor’s degree within a technical field preferred
• 2+ years of experience working within a Quality role in an ISO 9001 or ISO 13485 environment preferred
• Strong interpersonal, written/verbal communication, and critical thinking skills
• Proven ability to identify and execute process improvements
• Attention to detail and high level of accuracy
• Positive team building skills with a focus on providing exceptional customer service to internal and external parties
• Strong computer skills in Office products: Outlook, Excel, Word, etc.

Benefits

What you'll get: A competitive salary. Health benefits, retirement, stock options. A flexible work environment. A voice.  Each member of our team is a valued contributor working toward a common goal: affordable healthcare, worldwide.