Quality Manager

Description

The Quality Manager is a senior leader in a manufacturing facility, accountable for establishing and maintaining a robust Quality Management System that meets FDA Class 1 and Class 1 Exempt medical‑device requirements. You will develop and deploy the facility quality plan, align resources, and foster a culture of quality that supports both the strategic quality plan and the broader business objectives.

• Develop and deploy the facility quality plan aligned with corporate strategic quality objectives.
• Allocate and train resources to execute day‑to‑day quality activities.
• Engage and influence cross‑functional teams—including product development, logistics, and suppliers—to sustain a focused quality culture.
• Maintain a compliant QMS that meets FDA Class 1 medical‑device requirements and customer specifications.
• Act as Quality Management Representative for third‑party and regulatory audits.
• Lead the Quality Management Review process and ensure timely completion of assigned actions.
• Chair the CAPA review board, providing resources for effective corrective actions.
• Authorize rejection of non‑conforming raw materials and manage supplier corrective actions via SCAR.
• Oversee process validation execution and adherence to master validation plans.
• Guarantee finished‑product conformity to specifications and accurate device history records.
• Hold and manage non‑conforming or potentially non‑conforming product through escalation procedures.
• Ensure calibration of on‑line test equipment and qualification of testing personnel.
• Develop and deploy internal audit plans, building lead‑auditor capability across the site.
• Select, monitor, and review critical quality KPIs using run‑to‑target methodologies.

Requirements

To succeed you will need a bachelor’s degree in a relevant scientific discipline and typically seven or more years of experience in manufacturing quality, including people‑management and FDA medical‑device compliance. Experience as a Quality Management Representative for third‑party or regulatory audits, a strong track record building quality talent, and willingness to travel up to 10 % are also required; ASQ certification is desirable.

• Bachelor’s degree in a scientific field with 7+ years of manufacturing quality experience.
• Demonstrated people‑management and leadership in building quality talent.
• Working knowledge of FDA medical‑device regulations and experience as a QMR in audits.
• Travel up to 10 % to Neenah staff sites; ASQ certification preferred.

Benefits

Kimberly‑Clark’s legendary brands—including Huggies®, Kleenex®, Scott®, Kotex®, and many more—are trusted by millions across 175 countries. With more than 150 years of market leadership, the company continuously seeks innovative ways to improve performance and impact, offering you the opportunity to be part of a purpose‑driven organization.

Our performance culture is fueled by authentic caring, sustainability, inclusion, wellbeing, and career development. Employees enjoy flexible hybrid work arrangements, a collaborative environment that puts safety, respect, and human dignity at the center, and a commitment to continuous learning and new ideas.

Kimberly‑Clark offers comprehensive benefits such as medical, dental, and vision coverage with no waiting periods, on‑site fitness facilities, safety‑equipment allowances, flexible spending accounts, income‑protection insurance, and programs that support education, adoption, relocation, and temporary childcare.

Training + Development

Interview process

Visa Sponsorship

Security clearance