Quality Assurance Manager

Quality Assurance ManagerLocated in Westlake Village, CA; Onsite - No remote option.Caldera Medical’s Mission - To Improve the Quality of Life for Women!Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. Caldera has been ranked one of Inc 5000’s fastest growing private companies in the United States three times already. We develop, build and market best in class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, as well as Polyps and Fibroids.Responsibilities:Manage the Quality Affairs teamDevelop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured.Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements.Develop strong partnerships with R&D, manufacturing, marketing, sales and regulatory.Ensure compliance with applicable FDA and ISO requirements.Qualifications:BS in Engineering or Science8 years relevant experience in a regulated environment (preferably Medical Device)2 years directly supervising employees in qualityDesired Knowledge, Skills, and Abilities:Good problem-solving, critical thinking skillsStrong written and verbal communicationSense of urgencyContinuous improvementLeadership presenceOracle experience is a plusCompetitive Compensation and Benefits:$125,000 annual salary10% variable based on MBOsMedical / Dental Benefits – 75% paid for employees and family membersVision InsuranceBasic Life and AD&D401(k) with 4% matching contributionsUnlimited Vacation10 Paid Holidays6 Weeks of Paid Maternity LeaveBeing surrounded by talented and engaged employeesCaldera 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.

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