Document & Record Control Manager - Kohler Ventures

Document & Record Control Manager - Kohler VenturesWork Mode: HybridLocation: Hybrid, 3 days/week onsite in Palo Alto, CAOpportunityKohler 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 Document and Record Control Manager who is passionate about Quality Systems and building products for health and wellness. The candidate should also have a desire to work with other likeminded Quality professionals in building a Quality Culture that will transform the company into a premier wellness device manufacturer.  The ideal candidate will have demonstrated a successful track record working in a regulated industry. In your role as a Document and Record Control Manager at Kohler Ventures you will:Take on full responsibility and life cycle management as Lead administrator for the company’s Document Management System. This includes the Learning Management System.Acts as key point of contact for users and provides customer support and troubleshooting for creation and editing of documents and workflows.Provides reports and assists with management review on key performance metrics of the documentation system.Supports associate training in all aspects of the Document Management System.Supports initial product complaint in-take and customer contact through investigation to resolution.Author or review and approve documentation associated with the Quality Management ystem.Supports design & development and manufacturing sites in all aspects of local document management.Supports regulatory agency inspections and notified body inspections in concert with the Kohler Ventures Management Representative in all functions and capacities.Lead or participate in internal audits. Provide recommendations for corrective and preventive action as appropriate.As required, support site audits, non-conforming events, and CAPA’s.Skills/Requirements5+ years of demonstrated success as Lead administrator for a tier one Document and Learning Management System. QT9, Arena, or comparable medical device doc control software experience is preferred.Bachelor's Degree in Life Science or other related fields.5+ years’ experience working in a medical device company as a Lead administrator for the Document Management and Learning System.Experience in all aspects of medical device document content including but not limited to: SOP/WI, CAPA, Complaints, Non-conformances, DHR, DMR, CAD, and Procurement.Experience in technical writing related to wellness devices.Experience in developing SOPs, work instructions and report templates and training personnel in accordance with applicable regulations.Working knowledge of regulations and standards set forth under FDA, ISO standards and Agile software development.Minimal travel as needed.#LI-NR1#LI-HybridWe will consider applicants requiring sponsorship for this opportunity.The approved base salary range for this position is 103,950 - $138,650. 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 $120,582- $180,245 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 UsIt 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.