MedTech Document Control Specialist — Fast-Paced QA

Capstan Medical; Santa Cruz (CA); Sur place; USD 85 000 - 115 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision coverage

Flexible time off

Team outings and events

Résumé du poste

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.

Qualifications

• Bachelor's degree required with 3+ years in a regulated healthcare quality role.
• Experience drafting, revising, or maintaining quality procedures, WIs, SOPs, forms, and templates.
• Experience managing controlled documents through revision, approval, release, training, and archival workflows.
• Familiarity with 21 CFR Part 820/QMSR and ISO 13485 preferred.

Responsabilités

• Manage document workflows within Propel eQMS including creation, routing, approval, release, and obsolescence.
• Track and support change orders from creation through release, ensuring timely execution.
• Draft, revise, format, route, and review WI/SOP content and forms.
• Collaborate with quality and cross‑functional SMEs to update content and coordinate training impact assessments.
• Create and maintain training programs and records for all employees.
• Maintain the in‑house standards library, including indexing, status tracking, and updates.

Connaissances

Technical writing

Attention to detail

Organizational skills

Cross-functional communication

Auditing support

Formation

BA/BS degree in a related field

Outils

Propel eQMS

eQMS/ePLM

SharePoint

Microsoft Office

Description du poste

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.