Quality Manager

Quality Manager

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 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 and Class 1 Exempt Medical Device 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.

In this role, you will:


* Develops and deploys the facility quality plan ensuring alignment with the K-C North America Strategic Quality Plan 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 facility management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.


* Establishes and maintains the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 and Class 1 Exempt products and other customer requirements.


* Serves as the Quality Management Representative for 3rd party and regulatory audits.


* Leads the Quality Management Review process for the facility and responsible for ensuring actions are assigned and complete.


* Leads the CAPA review board for the facility ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments.


* 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 the facility process validation system is executed appropriately and maintains compliance to medical device expectations and master validation plans.


* Ensures finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record.

Has authority to hold non-confo...