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Quality Assurance Manager

3 months ago

Westlake Village, United States Caldera Medical Full time
Job DescriptionJob Description

Quality Assurance Manager

Located 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 team
  • Develop/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 Science
  • 8 years relevant experience in a regulated environment (preferably Medical Device)
  • 2 years directly supervising employees in quality

Desired Knowledge, Skills, and Abilities:

  • Good problem-solving, critical thinking skills
  • Strong written and verbal communication
  • Sense of urgency
  • Continuous improvement
  • Leadership presence
  • Oracle experience is a plus

Competitive Compensation and Benefits:

  • $125,000 annual salary
  • 10% variable based on MBOs
  • Medical / Dental Benefits – 75% paid 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
  • Being surrounded by talented and engaged employees

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.