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Quality Assurance Lead for Software and Compliance
2 months ago
The Quality Assurance Lead for Software and Regulatory at Kohler Ventures plays a pivotal role in ensuring the integrity and compliance of health and wellness products. This hybrid position requires a blend of onsite collaboration and remote work, primarily based in Palo Alto, CA.
About Kohler Ventures:
Kohler Ventures, a subsidiary of Kohler Co., is dedicated to innovating digital solutions that enhance consumer health and wellness. Our commitment to excellence drives us to integrate cutting-edge technology, design, and science into our products.
Key Responsibilities:
- Oversee all facets of Software Quality Assurance in a regulated environment, ensuring compliance with established policies and procedures.
- Contribute to the development of an electronic Quality Management System that adheres to relevant regulations, including 21 CFR Part 820 and ISO 13485.
- Engage with stakeholders to interpret regulations and establish quality procedures that mitigate product risks.
- Ensure that products meet industry standards and regulatory guidance, including FDA Design Controls and IEC standards.
- Author and review essential documentation related to qualification planning, user requirements, and design specifications.
- Monitor changes to existing systems from a QA perspective, ensuring compliance with internal and external standards.
- Review test results to ensure adherence to Good Documentation Practices and manage discrepancies effectively.
- Support regulatory inspections and audits, providing insights and recommendations for corrective actions.
Qualifications:
The ideal candidate will possess:
- A minimum of 5 years of experience in Software QA roles within the health sector.
- Proven expertise in Quality Management Solutions and regulatory compliance.
- A Bachelor's Degree in Engineering, Computer Science, or Life Sciences.
- Familiarity with wellness product regulations and the software development lifecycle.
- Experience with software testing, verification, and validation processes.
- Strong technical writing skills and experience in developing SOPs and training materials.
- Knowledge of regulations under 21 CFR Part 820, ISO 13485, and IEC 62304.
Work Environment:
This role requires flexibility to work across various time zones and may involve occasional travel. Kohler Ventures values diversity and inclusion, offering a supportive environment for all associates.
Compensation:
The compensation package includes a competitive salary, performance bonuses, and comprehensive benefits to support health and well-being.
