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Quality Assurance Manager - Westlake Village, United States - Caldera Medical
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Description
Quality Assurance Manager
Caldera Medical, located in Westlake Village, CA, is a growth stage medical device company dedicated to enhancing the quality of life for women. The company has been recognized as one of Inc 5000's fastest-growing private enterprises in the United States multiple times.
Responsibilities:
- Manage the Quality Affairs team
- Develop, enhance, and maintain processes and procedures to ensure robust product designs and consistent product quality
- Ensure timely and robust incoming inspection and collaborate with suppliers to drive quality enhancements
- Cultivate strong partnerships with R&D, manufacturing, marketing, sales, and regulatory teams
- Ensure compliance with FDA and ISO requirements
Qualifications:
- BS in Engineering or Science
- 8 years of relevant experience in a regulated environment (preferably Medical Device)
- 2 years of direct supervision experience in quality
- Desired Knowledge, Skills, and Abilities:
- Strong problem-solving and critical thinking skills
- Effective written and verbal communication
- Commitment to continuous improvement
- Leadership qualities
- Oracle experience is a plus
Competitive Compensation and Benefits:
- $125,000 annual salary
- 10% variable bonus based on MBOs
- Medical / Dental Benefits - 75% covered for employees and family members
- Vision Insurance
- Basic Life and AD&D
- 401(k) with 4% matching contributions
- Unlimited Vacation
- 10 Paid Holidays
- 6 Weeks of Paid Maternity Leave
- Engaging work environment with talented colleagues
Caldera Medical is an equal opportunity employer and welcomes all applicants, regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status, sexual orientation, gender identity, or any other category protected by law.