QA Lead - Kohler Ventures

QA Lead - Kohler Ventures Work Mode: Hybrid Location: Hybrid in Palo Alto, CA, 3 days/week onsite. Remote option is available for the right candidate. Opportunity Kohler Ventures is an independent company wholly owned by Kohler Co., a 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. The QA Lead reports to Head of Regulatory Affairs – Kohler Ventures and will have direct reports as the business continues to scale up in 2024 and beyond. In your role as the QA Lead at Kohler Ventures, you will provide the following for the Seoul (Hardware Development) and Cheonan (Production) sites: Lead the development and deployment of a Quality Management System compliant with US FDA QSR (21 CFR Part 820) or ISO 13485. Interpret the regulations and standards and engage with internal stakeholders to devise complaints, quality procedures, and processes that consider the risk of the product. Oversee the training of the organization in QMS processes and procedures, develop curricula, and monitor training compliance. Establish and lead change control and CAPA boards for the company. Interface and work closely with QA counterparts located in the US in order to align on QMS documentation and processes across global Kohler Ventures. Conduct broad and comprehensive analyses of key industry best practices and regulatory trends regarding quality management systems and provide updates to the technical teams. Lead QMS regulatory agency inspection readiness and inspections. Debrief management on audit outcomes and recommend corrective and preventive action items. Participate in the selection of a Notified Body and certify the company for ISO 13485. Represent the company on behalf of Quality on select industry working groups. Skills/Requirements Required Qualifications: 10 years with Quality Management Solutions (QMS) implementation and oversight. 10 years of demonstrated success in a fast-paced quality management role for MedTech hardware development and production. Experience in creating a QMS for start-ups and then scaling it accordingly through new product development to market launch with maintenance and continuous improvement throughout the product lifecycle. Bachelor's Degree in Engineering, Computer Science, or Life Sciences. Working knowledge of the medical device regulations set forth under US FDA QSR (21 CFR Part 820) or ISO 13485. Proven ability to successfully collaborate with internal stakeholders from various levels and areas of the organization and drive successful outcomes cross-functionally. Experience working closely with a hardware engineering and production organization to define quality requirements and manage them through the entire product development lifecycle. Experience in developing SOPs and work instructions and training personnel in accordance with applicable regulations. Travel as needed between Seoul and Cheonan sites. Preferred Qualifications: Certifications are a plus, such as Lead Quality Auditor. Experience with QT9 PLM/QMS, SAP MRP, and Salesforce CRM. Working knowledge of the medical device regulations set forth under IVDR and MDSAP. Working knowledge of GCP practices and ISO 14155. Applicants must be authorized to work in the US without requiring sponsorship now or in the future. 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. 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 kohlerjobskohler.com . Kohler Co. is an equal opportunity/affirmative action employer. J-18808-Ljbffr