Software Quality Assurance Lead

1 week ago


Palo Alto, California, United States Kohler Full time
Job Title: Software Quality Assurance Lead

We are seeking a highly skilled Software Quality Assurance Lead to join our team at Kohler Ventures. As a key member of our software development team, you will be responsible for ensuring the quality and compliance of our software products in the health and wellness space.

Key Responsibilities:
  • Develop and implement software quality assurance processes and procedures to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to design and develop software products that meet quality and regulatory standards.
  • Conduct software testing and verification/validation to ensure compliance with 21 CFR Part 820, ISO 13485, and other relevant regulations and standards.
  • Develop and maintain design history files and technical files for software products.
  • Support regulatory agency inspections and audits.
Requirements:
  • 5+ years of experience in software quality assurance roles for hardware/software products in the health space.
  • Experience with Quality Management Solutions (QMS) implementation and oversight.
  • Bachelor's Degree in Engineering, Computer Science, or other Life Sciences.
  • ASQ certifications are a plus.
What We Offer:

We offer a competitive salary range of $124,450 - $158,550, depending on location, as well as a performance bonus and special project incentive. Our benefits package includes medical, dental, vision, and 401k. We are an equal opportunity/affirmative action employer and welcome applications from diverse candidates.



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