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Senior Quality Specialist

BioTalent · biotalent.com
Aliso ViejoSenior3+ yrs
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The job in short

Quality specialist.

ExcelAuditSupply chain

Details

Found
11 d ago · posted 2026-09-15
Location as listed
Aliso Viejo, CA, US
Role
Quality Engineer
Source
The company’s own careers site

Full description

Summary 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

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