Quality Assurance Lead for Software and Compliance

2 weeks ago


Palo Alto, California, United States Kohler Full time
Position Overview:

Kohler Ventures is seeking a QA Lead with a focus on software and regulatory compliance in the health and wellness sector. This role is pivotal in ensuring that our products meet the highest standards of quality and safety.

Work Environment:
Hybrid model with three days onsite.

About Kohler Ventures:
Kohler Ventures, a subsidiary of Kohler Co., is dedicated to developing innovative digital solutions that promote healthier lifestyles. We leverage cutting-edge technology and design to enhance user experiences and create new business opportunities.

Key Responsibilities:
1. Oversee all aspects of Software Quality Assurance within a regulated environment, ensuring compliance with established policies and procedures.
2. Assist in the development of an electronic Quality Management System that adheres to relevant regulations such as 21 CFR Part 820 and ISO 13485.
3. Collaborate with internal teams to interpret regulations and create quality procedures that address product risks.
4. Ensure products meet regulatory standards and guidance, including FDA Design Controls and IEC standards.
5. Author and review critical documentation related to qualification planning, user requirements, and test protocols.
6. Evaluate changes to existing systems from a QA perspective, ensuring compliance with internal and external standards.
7. Conduct reviews of test results to ensure adherence to Good Documentation Practices.
8. Support regulatory inspections and audits, providing management with insights and recommendations for improvement.

Qualifications:
- Minimum of 5 years of experience in Software QA roles, particularly in health-related products.
- Proven track record in Quality Management Solutions (QMS) implementation.
- Bachelor's Degree in Engineering, Computer Science, or a related field.
- Familiarity with wellness product regulations and the software development lifecycle.
- Experience with software testing and validation processes.
- Proficient in software configuration and issue tracking tools.
- Strong technical writing skills for software development documentation.
- Knowledge of regulations such as ISO 13485 and IEC 62304.
- Willingness to work flexible hours and travel as needed.

Compensation:
The approved salary range for this position is competitive and may vary based on experience and location. Additional benefits include performance bonuses and a comprehensive health package.

Why Kohler?
Kohler is committed to fostering a diverse and inclusive workplace, offering opportunities for career growth and a culture of innovation. We empower our associates to excel and contribute to meaningful change in the health and wellness industry.

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