Complaint Specialist/CAPA Analyst
$75k/y-$75k/y
20 hours ago
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OnsiteFull-timeMid
Summary
Caldera Medical is seeking a Complaint Specialist/CAPA Analyst to join their Quality team in Westlake Village, California. The role involves overseeing product complaint handling, trending, and reporting while managing Corrective and Preventive Action (CAPA) activities to ensure compliance with regulatory requirements.
About the Role
As a Complaint Specialist/CAPA Analyst, you will manage the end-to-end complaint handling process, ensure timely evaluations, collaborate with cross-functional teams to investigate complaints, and lead the CAPA process. You will also track and analyze complaint data, support audits, and contribute to continuous improvement initiatives within the Quality Management System.
About You
Required:
- Minimum of 4+ years of experience handling product complaints and working on CAPA.
- Experience working within the medical device industry and familiarity with 21 CFR 820 and ISO 13485 regulations.
- Proficient in Microsoft Power Point, Excel, Outlook, Microsoft Word, and Teams.
- Excellent analytical, organizational, and communication skills.
Preferred:
- Bachelor's degree preferred.
- Experience with complaint handling, risk management, or audit support.
Benefits
- $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
Caldera Medical
Caldera Medical is a medical device company solely focused on women’s health with a commitment to our mission of “Improving the Quality of Life for Women!” We develop, build and market best in class surgical products for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Working closely with surgeons to help those here at home, as well as women around the world, through our humanitarian programs to give them the access to the education and treatment they deserve. Mission - To Improve the Quality of Life for Women Vision - To be the Global Leader in Women's Pelvic Health Values "C4" - Care / Collaborate / Challenge / Create
Westlake Village, CA