Amplify Surgical has an immediate opening for a Quality Engineer. This highly visible position, reporting to the VP of Operations, is responsible for meeting and exceeding goals by advancing high quality spinal fusion solutions utilizing cutting-edge implant technology.
The quality engineer will be responsible for supporting the operations organization with day-to-day, near term, and long-term execution of quality tasks. The position requires strong interpersonal skills, with the ability to quickly meet supply chain requirements and support customer service, sales, engineering and operations departments.
Responsibilities
Document Control
- Routing, release, and control of quality system documents
- Assign, monitor, and retain training records
ASL (Approved Supplier List)
- Maintain supplier qualification status
- Audit and audit program
- Support supplier quality activities
Control of Nonconforming Material & Complaints
- Create and manage CAPA & complaint program
- Nonconforming material investigations and segregation activities
- Quality Management Review
Incoming and Outgoing Inspection
- DMR review
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