Quality Manager - Kohler Ventures

Work Mode: Hybrid

Location: Hybrid (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 fieldspreferred.

• 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 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.