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Kimberly-Clark · 1 day ago

Quality Manager

Neenah, WI

Full-time

Hybrid

Senior Level

$128K/yr - $158K/yr

7+ years exp

Kimberly-Clark is a leading company known for its iconic brands and commitment to quality. The Quality Manager will be responsible for establishing and maintaining a robust Quality Management System compliant with FDA regulations, while driving a culture of quality throughout the manufacturing facility.

ManufacturingProduct DesignWholesale

No H1B

Responsibilities

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-conforming or potentially non-conforming product. Accountable to manage non-conforming 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 inspection 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

Qualification

Quality Management SystemFDA Medical Device ComplianceQuality Management RepresentativeCAPA ManagementPeople ManagementManufacturing ExperienceQuality Management QualificationInternal AuditsLeadership Skills

Required

Bachelor's degree in a relevant scientific discipline and typically 7+ years experience in targeted area

Extensive experience in a Manufacturing and relevant Quality role

Demonstrated people management experience

Working knowledge and experience with products requiring compliance to FDA medical device regulations

Experience as a Quality Management Representative in 3rd party and/or Regulatory audits

Background in managing Medical Device Quality Management Systems

Leadership skills in building quality talent throughout a manufacturing facility

Strong track record of meeting business objectives as a key business partner

Travel up to 10% of the work time primarily to Neenah staff site locations

Preferred

A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Manager of Quality Organizational Excellence / Auditor