Quality Assurance Lead for Software and Regulatory Compliance

3 weeks ago

Palo Alto, California, United States Kohler Full time

Job Summary:

Kohler Ventures is seeking a Quality Assurance Lead to join our team in Palo Alto, CA. As a Quality Assurance Lead, you will be responsible for ensuring the quality and regulatory compliance of our software and hardware products in the health and wellness space.

Key Responsibilities:

  • Actively contribute to all aspects of Software Quality Assurance activities in FDA-Regulated environment and ensure that software verification and validation is carried out in compliance with the policies and procedures.
  • Support development of an electronic Quality Management System compliant with 21 CFR Part 820, ISO 13485, and other relevant regulations and standards.
  • Interpret applicable regulations and standards and engage with internal stakeholders to devise complaints, quality procedures and processes that consider the risk of the product.
  • Responsible for ensuring product meets standards (where applicable) and guidance such as FDA Design Controls CFR 820.30, IEC 62304 – Software Life Cycle Processes, IEC 14971 – Risk Management, ISO 13485 – Quality Management Systems, 2017/745 – (EU MDR).
  • Author or Review and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix and qualification report along with support documentation for equipment and systems.
  • Review and approve changes to existing systems from a Software QA perspective, making sure changes are implemented in compliance with internal procedures and external standards.
  • Review test results for compliance with Good Documentation Practices and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.
  • Ensure that best software QA practices are employed by all departments so that software/firmware-based systems are developed, qualified, and maintained in a manner which provides assurance that the system conforms to both internal and external requirements.
  • Support regulatory agency inspections in concert with the Kohler Ventures Management Representative in all functions and capacities.
  • Debrief management on audit outcomes, share trends and findings, and recommend corrective and preventive action items.
  • As required, support site audits, non-conforming events, and CAPA's.
  • Lead change management activities for software/firmware.

Requirements:

  • 5+ years of demonstrated success in fast-paced Software QA roles for hardware/software products in the health space.
  • 5+ years with Quality Management Solutions (QMS) implementation and oversight.
  • Bachelor's Degree in Engineering, Computer Science or other Life Sciences.
  • ASQ certifications are a plus.
  • 5+ years of experience with wellness product regulations for hardware and the software development life cycle (SDLC).
  • Experience in software testing and verification/validation
  • Experience in developing and maintaining design history files and technical files.
  • Experience with software configuration, and issue tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
  • Experience in technical writing for software development processes and deliverables
  • Experience in developing SOPs, work instructions and report templates and training personnel in accordance with applicable regulations.
  • Working knowledge of the regulations and standards set forth under 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.
  • Availability to work outside of standard business hours as needed to be able to collaborate with teams across multiple time zones.
  • Ability to travel 10% of time both domestically and internationally.

About Kohler:

Kohler Ventures is an independent company wholly owned by Kohler Co., global leader in the manufacture of kitchen and bath products, tile and home interiors, and an international host to award-winning hospitality and world-class golf destinations.

We empower each associate to #BecomeMoreAtKohler with a competitive total rewards package to support your health and wellbeing, access to career growth and development opportunities, a diverse and inclusive workplace, and a strong culture of innovation.

With more than 30,000 bold leaders across the globe, we're driving meaningful change in our mission to help people live gracious, healthy, and sustainable lives.

We are an equal opportunity/affirmative action employer and welcome applications from diverse candidates.

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