Senior Quality Specialist

Senior Quality Specialist

We have an immediate opening for a Senior Quality Specialist. This highly visible position is responsible for meeting and exceeding goals by advancing high-quality spinal fusion solutions utilizing cutting-edge implant technology. This role supports the operations organization with day-to-day, near-term, and long-term execution of quality tasks, requiring strong interpersonal skills and the ability to quickly meet supply chain requirements while supporting customer service, sales, engineering, and operations departments.

Responsibilities:

• Route, release, and control quality system documents
• Assign, monitor, and retain training records
• Maintain supplier qualification status
• Support the audit program and supplier quality activities
• Create and manage the CAPA and complaint program
• Lead nonconforming material investigations and segregation activities
• Support Quality Management Review
• Conduct DMR review for incoming and outgoing inspection
• Support development and maintenance of quality plans

Requirements:

• Bachelor's degree
• 3+ years of medical device experience
• Proficiency in Microsoft Office suite (Outlook, Excel, Word, PowerPoint, etc.)
• Ability to thrive in a startup environment
• Experience with an orthopedic medical device company or spine experience a plus
• ISO 13485 QMS auditor certificate