Quality Manager - Beech

Overview

Quality Manager - Beech Island

As a person, you’re a learner – a natural leader – someone who is always taking initiative to make things better and bring others along with you. You live your life in alignment with the highest values of integrity and quality, always ensuring your responsibilities become a long-term success story. In this role, you’ll help us deliver better care for billions of people around the world.

It starts with YOU.

Summary of Position:

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) compliant with FDA Class 1 Medical Device, FDA Cosmetics 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.

This position reports to the Senior Quality Manager (staff) with a dotted line to the Beech Island Plant Manager.

In this role, you will be responsible for:

• Develops and deploys the facility quality plan ensuring alignment with the K-C North America Quality Objectives and Supply Chain Strategic Business Plan.
• Ensures adequate resources are available and trained to implement the facility quality plan and required day-to-day activities.
• Engage with and influence the plant 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 employees responsible for supporting plant quality systems and standards.
• Manage yourself, your team and your interactions with others in accordance with the 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
• Establishes and maintains the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 products, FDA Cosmetics and other customer requirements.
• Serves as the Quality Management Representative for 3rd party, regulatory and K-C global audits.
• Leads the Quality Management Review process for the facility and responsible for ensuring actions are assigned and complete.
• Leads 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.
• Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
• Ensures 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.
• Ensures the on-line asset test equipment and product test laboratory equipment is calibrated and all personnel performing product testing or inspections are qualified.
• Ensures internal audit plans are developed and deployed and builds capability for lead auditors across the site to conduct internal audits.
• Ensures that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies.

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