Quality Manager - Warren, OH

Job Description

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You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground‑breaking brands. In this role, you’ll help us deliver better care for billions of people around the world.

It starts with YOU.

• Develop and deploy the facility quality plan ensuring alignment with the K‑C North America Quality Objectives and Supply Chain Strategic Business Plan.
• Ensure adequate resources are available and trained to implement the facility quality plan and required day‑to‑day activities.
• Engage with and influence the facility management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.
• Provide mentorship and direction for quality professionals plant‑wide. This includes, but is not limited to, providing strategic guidance and coaching to the system skill roles responsible for supporting plant quality systems and standards.
• Manage yourself, your team and your interactions with others in accordance with the principles and tenets of the plant’s High Performance Work System and expected K‑C Values:
  We Care, We Own, We Act and Ways of Working:
  Focus on Consumers, Play to Win, Move Fast and Grow our People.
• Establish and maintain the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 products and other customer requirements.
• Serve as the Quality Management Representative for 3rd party, regulatory and K‑C global audits.
• Lead the Quality Management Review process for the facility and ensure actions are assigned and complete.
• Lead the CAPA/ QNC review board for the facility ensuring all employees associated with CAPA/ QNC action items have the capabilities and resources to complete their assignments in a timely manner.
• Ensure incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicate material issues and partner with suppliers to improve performance through the SCAR process as appropriate.
• Ensure finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record where applicable. Hold nonconforming or potentially nonconforming product and manage nonconforming product through the escalation procedures.
• Ensure the on‑line asset test equipment and product test laboratory equipment is calibrated and all personnel performing product testing or inspections are qualified.
• Ensure internal audit plans are developed and deployed and build capability for lead auditors across the site to conduct internal audits.
• Ensure that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run‑to‑target methodologies.

You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. When you join our team, you’ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.

• Position typically requires a minimum of a bachelor’s degree in a relevant scientific or engineering discipline and typically 7+ years’ experience in the targeted area.
• Extensive experience in a manufacturing environment and relevant quality roles.
• Demonstrated people leader experience including career development and succession planning.
• Working knowledge and experience with products requiring compliance to FDA medical device and Consumer…