Complaint Specialist/CAPA Aalyst

100% ONSITE - in Westlake Village, California

Message from the Hiring Manager:

We are seeking a detail-oriented and proactive 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

• Lead and coordinate the CAPA process, ensuring proper documentation, investigation, root cause analysis, action plan development, and verification of effectiveness.
• Monitor CAPA progress to ensure timely closure in compliance with internal procedures and regulatory requirements.
• Collaborate with stakeholders to implement preventive measures that improve processes and reduce recurrence of issues.
• Maintain CAPA records in the Quality Management System (QMS) and generate metrics for management review.
• Support continuous improvement initiatives within the QMS, leveraging complaint and CAPA data for proactive risk reduction.
• Additional duties may be assigned as needed and are not limited to those listed above.

Required Knowledge, Skills and Abilities:

• Minimum of 4-5 years of experience handling product complaints and working on CAPA.
• Bachelor's degree preferred.
• Experience working within medical device industry and familiarity with 21 CFR 820, and ISO 13485 regulations.
• Proficient in Microsoft Power Point, Excel, Outlook, Microsoft Word and Teams.
• Experience with complaint handling, risk management, or audit support is a plus.
• Excellent analytical, organizational, and communication skills.

Competitive Compensation, Comprehensive Benefits, and more!

• $75k Annual Salary
• Medical and Dental Benefits – 75% paid for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays- including your birthday!
• Being surrounded by amazing people!

(This role is being filled internally, and we are not engaging external agencies at this time.)

Our Culture- Where Career and Passion come together!

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

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.