Complaint Specialist / CAPA Analyst

Job Description

Job Description

Complaint Specialist / CAPA Analyst

100% ONSITE - in Westlake Village, California

Sponsorship is not available for this role.

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

Message from the Hiring Manager :

We are seeking a Complaint Specialist / CAPA Analyst to join our Quality team. This position is responsible for overseeing product complaint handling, trending, and reporting while also managing Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA, ISO, and other applicable regulatory requirements. The ideal candidate will have strong analytical skills, experience in regulated industries, and the ability to collaborate across functions to drive effective resolutions.

Duties and Responsibilities :

Complaint Handling

• Manage end-to-end complaint handling process, from intake and documentation to investigation and closure, in accordance with internal SOPs and regulatory requirements.
• Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions.
• Collaborate with cross-functional teams (Quality, Engineering, Regulatory, Manufacturing, Customer Service) to investigate complaints, determine root cause, and define appropriate corrective actions.
• Track, trend, and analyze complaint data, preparing periodic reports and metrics for management review.
• Support audits and inspections by providing complaint records and demonstrating process compliance.

CAPA Management

Required Knowledge, Skills and Abilities :

Competitive Compensation, Comprehensive Benefits, and more!

Our Culture- Where Career and Passion come together!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.