QA Lead Software and Regulatory - Kohler Ventures

Work Mode: Hybrid

Location: Hybrid 3 days/onsite in Palo Alto, CA

Opportunity

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. Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations developed through the integration of leading-edge technology, science, and design. Come join us as we build a best-in-class global multi-disciplinary team across artificial intelligence, machine learning, design, advanced software and hardware engineering, strategy, venture investments, sales, marketing, and partnerships. Our locations are Palo Alto, CA US, New York City, NY US, Kohler, WI US, Seoul, Korea, and Tel Aviv, Israel.

We are seeking a QA Lead (Internal Title) who is passionate about designing and building products for health and wellness. The candidate should also have a desire to mentor and collaborate with the Software engineering team in implementing required regulatory and Software Lifecycle Management requirements for wellness products. The ideal candidate will have a successful track record for working on regulatory and software lifecycle management methodologies for products related to health and wellness and mentoring technical professionals on these requirements.

Specific 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.

Skills/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.

#LI-NR1

#LI-Hybrid

We will consider applicants requiring sponsorship for this opportunity.

The approved base salary range for this position is $124,450 - $158,550. The actual base salary offered to a candidate may be higher than the approved range. This will vary depending on a variety of factors including the candidate’s experience, their education, and the work location. This position is subject to Area Salary Differential (Cost of Living Adjustment) that ranges from 24.5%-30% of base salary for the San Francisco Bay area. The approved base salary range including ASD for this position is $161,785 - $206,115 depending on location. In addition, this position is eligible for a performance bonus and a special project incentive. Available benefits include medical, dental, vision and 401k.

Why Choose Kohler?

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.

About Us

It is Kohler’s policy to recruit, hire, and promote qualified applicants without regard to race, creed, religion, age, sex, sexual orientation, gender identity or expression, marital status, national origin, disability or status as a protected veteran. If, as an individual with a disability, you need reasonable accommodation during the recruitment process, please contact kohlerjobs@kohler.com . Kohler Co. is an equal opportunity/affirmative action employer.