MedTech Document Control Specialist — Fast-Paced QA

Capstan Medical; Santa Cruz (CA); In loco; USD 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Capstan Medical, based in Santa Cruz, develops a robotic platform for minimally invasive heart valve treatment. The QA role focuses on document control, standardization, and training within a fast-paced, collaborative team.

You will manage Propel eQMS workflows, support audits, and maintain records while coordinating with cross-functional SMEs to ensure compliance with 21 CFR Part 820/QMSR and ISO 13485. The role emphasizes attention to detail, change control, and training program support to

Mansioni

• Manage Propel eQMS workflows
• Support audits and regulatory inspections
• Maintain quality records and document control
• Coordinate with cross-functional SMEs to ensure compliance

Descrizione del lavoro

Capstan Medical, based in Santa Cruz, is building a pioneering robotic platform for minimally invasive heart valve treatment. The Quality Assurance role focuses on document control, standardization, and training within a fast- paced, collaborative team.

You will manage Propel eQMS workflows, support audits, and maintain records while coordinating with cross‑functional SMEs to ensure compliance with 21 CFR Part 820/QMSR and ISO 13485.