Senior Quality Assurance Specialist — Medical Devices

Mendaera, Inc.; San Mateo (CA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Mendaera, Inc. is seeking a Senior Quality Assurance Specialist to lead Quality System operations for medical device products. You will report to the Sr. Manager, Regulatory Affairs and Quality Assurance and will not have any direct reports.

You will oversee document control, inspections, nonconformances, and CAPA processes while ensuring compliance with QSR and ISO requirements. The role emphasizes mechanics of quality systems and continuous improvement.

Qualifications

• 3+ years of medical device complaint handling experience.
• Familiarity with ISO 13485 & FDA quality systems.
• Experience with CRM & eQMS tools.

Responsabilités

• Document Control: manage QS documents, DCO reviews, and electronic filing in eQMS.
• Operations Quality Support: review materials, inspect and document nonconformances, investigate quality events.
• General Responsibilities: drive process improvements, ensure compliance with GMP/QMS.

Connaissances

Quality assurance

Inspection

Quality systems

Root cause analysis

Formation

AA degree or equivalent

Outils

Salesforce

Arena

Description du poste

Mendaera, Inc. is seeking a Senior Quality Assurance Specialist to lead Quality System operations for medical device products. You will report to the Sr. Manager, Regulatory Affairs and Quality Assurance and will not have any direct reports.

You will oversee document control, inspections, nonconformances, and CAPA processes while ensuring compliance with QSR and ISO requirements. The role emphasizes mechanics of quality systems and continuous improvement.