Quality & Regulatory Systems Specialist

Tenovi, an Inc. 5000 Company; Irvine (CA); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

Tenovi is hiring a Quality & Regulatory Specialist to manage the day-to-day quality system operations and keep FDA listings and device labeling compliant. This full-time individual contributor role collaborates with our regulatory advisor to roll out procedures, train staff, and maintain records in accordance with QMSR and ISO 13485.

You will perform receiving inspection, handle nonconformances and CAPAs, manage document control, and support internal and FDA audits.

Qualifications

• Bachelor's degree in a technical or scientific field.
• 2–4 years in quality assurance, quality control or regulatory work for medical devices or a regulated industry.
• Working knowledge of FDA QMSR and ISO 13485.
• Experience with document control and training records.
• Hands-on inspection or test experience with electronic products; able to follow procedures precisely.
• Strong written communication and ability to train colleagues.

Responsabilités

• Roll out procedures and tools and ensure teams follow them in daily work.
• Train staff on new procedures and maintain training records.
• Run document control: versioning, approval, distribution and retirement of controlled documents and records.
• Support quality processes such as nonconformances, CAPAs, complaint handling and supplier controls.
• Keep records ready for internal audits, customer audits and FDA inspections, and support the audits themselves.

Connaissances

Quality assurance

Regulatory compliance

Documentation control

Training

Attention to detail

Quality systems

Formation

Bachelor's degree in a technical or scientific field

Outils

eQMS software

GS1

GUDID

FDA FURLS

GS1 product data

Description du poste

Tenovi is hiring a Quality & Regulatory Specialist to manage the day-to-day quality system operations and keep FDA listings and device labeling compliant. This full-time individual contributor role collaborates with our regulatory advisor to roll out procedures, train staff, and maintain records in accordance with QMSR and ISO 13485.

You will perform receiving inspection, handle nonconformances and CAPAs, manage document control, and support internal and FDA audits.