Quality Manager - Warren, OH

Quality Manager - Warren, OH Job Description

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.

The Plant Quality Manager is a key leadership position within a manufacturing facility with accountability to establish and maintain a robust Quality Management System (QMS) complaint with FDA Class 1 Medical Device and Consumer Product requirements and consistently capable of shipping product conforming to the Finished Product Specification (FPS) and other regulatory and customer requirements.

This role is key in building talent and quality system capabilities throughout the manufacturing facility aligned with K-C core values of putting quality into everything we do. The plant quality manager drives the culture of quality across the entire site in alignment with the strategic quality plan and supporting the business objectives. The incumbent should have a strong background in managing Medical Device Quality Management Systems, leadership skills in building quality talent throughout a manufacturing facility and have a strong track record of meeting business objectives as a key business partner.

This position reports to the Senior Quality Manager (staff) with a dotted line to the Warren Plant Manager. This position will manage a total staff of approximately 2-4 salary and 8-12 hourly employees.

• 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.
• Serves as the Quality Management Representative for 3rd party, regulatory and K-C global audits.
• Lead the Quality Management Review process for the facility and responsible for ensuring 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 partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) 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. Has authority to hold nonconforming or potentially nonconforming product. Accountable to manage nonconforming product through the nonconforming material 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…