Quality Systems Leader
QA/RA | Agoura Hills, CA | Full Time
Quality Systems Leader – Agoura Hills, CA
Caldera Medical’s Mission - To Improve the Quality of Life for Women!
Message from the Hiring Manager:
“Are you interested in playing a major role supporting our rapid growth? We are seeking a Quality Systems Leader to manage the Quality Affairs Department. Including the following key accountabilities: develop processes to ensure robust product designs and consistent manufacturing of the highest product quality; develop strong partnerships with R&D, manufacturing, marketing, sales and regulatory; and drive continuous improvement to ensure compliance with applicable FDA and ISO requirements.”
Duties and Responsibilities:
- Build strong partnerships with R&D, Regulatory, Manufacturing, Sales and Marketing functions.
- Manage all QA Department employee related activities (i.e., hires, training, appraisals, rewards, motivation, and discipline).
- Provide decisions and judgements regarding quality based on solid risk analysis.
- Manage design quality assurance processes and testing.
- Lead continuous improvement across our quality system including procedures, documentation systems, tools, metrics and measurable improvements to meet objectives and standards.
- Participate and support internal audits and external QMS audits.
- Manage CAPA/SCAR process and drive open corrective actions to closures.
- Ensure the company is operating in accordance with applicable standards and regulations.
- Interact with government agencies, healthcare organizations and medical professionals.
Required Knowledge, Skills and Abilities:
- Bachelor’s Degree in Engineering or Science
- 8 years of relevant experience in a regulated environment
- 2 years directly managing employees in quality within a small to mid-sized company.
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.
“It’s exciting to work for a company with high growth potential. More importantly, it’s meaningful and a delight to get up every day and singularly focus on improving women’s health worldwide.”
-Bahar Sutorius, Vice President, Operations
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 2025!
Competitive Compensation, Comprehensive Benefits, and more!
- 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!
Hear it from our very own! Learn more about Caldera on Glassdoor
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.