Quality Manager

Published
February 19, 2024
Location
W york

Description

uality Manager - Kohler Ventures Work Mode Hybrid LocationHybrid (2-3 days onsite) at New York City, NY (Manhattan)Opportunity Kohler Ventures is an independent company wholly owned by Kohler Co., a global leader in kitchen and bath, power generation, and hospitality. 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. We are seeking a Quality 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. The Quality Manager at Kohler Ventures is an individual contributor position with no direct reports. Specific Responsibilities In your role as a Quality 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 System. 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/Requirements Bachelor's Degree from an accredited institution is required. A degree in Life Science or other related fields preferred. 5+ years’ experience working in Quality Assurance at a medical device company required. 5+ years of demonstrated success as Lead administrator for a tier one Document Management System. Windchill (PTC product) experience is preferred. 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 preferred. Experience in technical writing related to wellness devices required. 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 both domestic and international as needed. #LI-NR1 #LI-Hybrid 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 $106,250 - $134,950. 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 a 16% Area Salary Differential (Cost of Living Adjustment) in the NYC metro area. The approved base salary range including ASD for this position is $123,250- $156,542 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 Work at Kohler Co.? Kohler Co.'s mission is to contribute to a higher level of gracious living for those who are touched by our products and services. We understand that it takes investment in our associates’ development to make that happen.So, we offer ongoing investment in each individual’s personal development and the opportunity to collaborate with others across functions and roles at Kohler. In addition to the investment in your development, Kohler offers a benefits package including a competitive salary, health, vision, dental, 401(k) with company matching, and more! *Important update for candidates applying to roles within Kohler Energy, including Power Systems, Engines, Home Energy, Kohler Uninterruptible Power, Clarke Energy, Curtis Instruments, and Heila Technologies. On November 6, Kohler Co. announced the strategic decision to establish Kohler Energy as a separate, independent business with Platinum Equity as the majority investment partner. Kohler will continue to stay invested in the Energy business following the closing and remains committed to supporting the acceleration of long-term growth strategies for both organizations. Talent and operational transition plans are underway, and Kohler Co. and Platinum Equity expect the agreement to close in the first half of 2024.Thank you for your interest in joining our growing team as we embark on the next phase of growth! About Us Beyond the competitive benefits and compensation, Kohler proudly offers a rich history, steeped in creativity and a commitment to our associates and communities.We invite you to learn more about our culture and company at www.kohlercompany.com. It is Kohler’s policy to recruit, hire, and promote qualified personnel in all job classifications 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. We invite you to learn more about equal employment opportunity by reviewing the Federal EEO is the Law and the EEO is the Law Supplement

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