QMS Coordinator

The Opportunity

Cala Health is seeking a QMS Coordinator based in the San Francisco Bay Area to join our team. This team member will be responsible for document control, complaint coordination and training coordination. The compensation for this role is a base salary of $70,000-$88,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy.

Specific Responsibilities include:

• Process documentation changes: manage the initial release of QS documents and revision of existing documents, managing the DCO reviews, and releasing documents within an electronic Quality Management System (eQMS)
• Ensure the eQMS (NCMR, CAPA, Quality Processes, and etc.) operates effectively and efficiently to meet the needs of internal customers, business objectives, and corporate quality objectives
• Evaluate and document product complaints, ensuring comprehensive responses
• Collaborate with cross-functional departments (Regulatory, Clinical, R&D, etc.) to gather essential information for the resolution of complaint investigations
• Setup, maintain, and monitor Cala Health (employees and consultants) training requirements and records in Cala Health’s eQMS
• Partner with managers and supervisors to ensure training requirements for newly hired team members/consultants are assigned and processed in eQMS.
• Drive continuous improvement by offering constructive feedback on existing processes
• Ensure compliance with all corporate, regulatory, safety, and production policies and procedures

Required Skills and Experience

• Minimum AA degree in a related field or equivalent level of experience
• 3+ years of medical device complaint handling process
• Familiarity and understanding in a regulated environment (ISO 13485 & FDA)
• Excellent technical verbal/written communication skills

Preferred Qualifications

• Familiarity with CRM system such as SalesForce, Arena, or equivalent
• Working knowledge using common inspection tools, including operation of automated visual inspection systems.
• Working statistical knowledge for trend analysis
• Experience working with MS Office and Excel or Google Docs and Sheets
• Process orientation when planning and performing work