Provides Quality leadership to assigned Product Platform(s). Serves as the key point of contact to facility, business or staff teams for the assigned Product Platform(s), covering routine Platform quality tasks such as change management, investigation and resolution of non-conforming product events, manufacturing data and metrics preparation and analysis, start-up protocol/process validation/verification planning, complaint management and routine problem-solving. Recommends and implements plans and projects that support business, team and/or organization objectives. Ensures compliance to established procedures and processes. Provides subject matter expertise for assigned manufacturing-focused quality system(s).
Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Planning, Procurement, Legal, Marketing, Component Suppliers, Consumer Services, and External Consultants.
General Expectations and Accountabilities:
Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
Manages self and team in accordance with the expected behaviors of the Leadership Qualities.
Effectively achieve results that meet business and individual objectives.
Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as FDA GMP requirements.
Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
Performs production and quality systems audits.
Maintain and demonstrate a high degree of knowledge and skill in product forms, quality systems, processes, and regulations.
Establish and maintain good customer rapport, while driving solutions to meet business needs.
Develop and maintain a strong spirit of partnership.
Conduct all communications and transactions with the utmost integrity.
Communicate fully with superiors, teammates, and others who have a need to know.
Executes continuous improvement activities for established processes and initiates/supports development of new processes.
Builds and maintains capability in QMS and GMPs to support objectives.
Position Specific Accountabilities:
Act as the primary routine decision-making Quality contact for brand platforms within the NCSF facility, providing quality leadership to Asset teams, Staff Quality and R&E teams in the areas of non-conforming product investigation and resolution, manufacturing quality controls, manufacturing quality planning, change management, manufacturing metrics & reporting, complaint investigations and start-up protocol/spec verification.
Initiates and follows up on manufacturing-related CAPA and QNC events.
Identifies need for, develops, and executes continuous improvement plans for manufacturing within the facility.
Builds and maintains capability with QMS, 21 CFR 820, and other regulations and GMP's.
Provide Quality Management support to asset teams and project teams, including support for change control, validation, and acceptance sampling, as needed.
Provides feedback for the development of new quality standards and systems to meet business objectives.
This position reports to the Neenah Cold Spring Facility Quality Manager. Has responsibility for coordinating manufacturing-related quality improvement projects, day-to-day support needs, complaint investigations and key metric reporting. Assists in or leads small to moderate-sized projects.
Normally requires a Bachelor’s degree in science, engineering or related discipline and 5+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function.
Experience should include close working relationships with Manufacturing and Research functions AND technical quality skills in at least two of the following areas: CAPA, applied statistics, validation, change management, complaint management, gage R&R, and/ or demonstrated application of LEAN/ Continuous Improvement skills. Knowledge of Medical Device requirements is strongly desired.
Position may require travel of up to 5% to support business requirements.
Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.
Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.
K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing.
Global VISA and Relocation Specifications:
K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion.
This position is subject to drug and alcohol testing, including pre-employment testing.