Quality Assurance Manager - Westlake Village, United States - Caldera Medical

Caldera Medical
Caldera Medical
Verified Company
Westlake Village, United States

1 week ago

Mark Lane

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Mark Lane

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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.
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Qualifications:
  • BS in Engineering or Science
  • 8 years relevant experience in a regulated environment
  • 2 years directly supervising employees in quality

Desired Knowledge, Skills, and Abilities:


  • Good problemsolving, critical thinking skills
  • Strong written and verbal communication
  • Sense of urgency
  • Continuous improvement
  • Leadership presence

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
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