This position is for a Senior Quality Engineer - Global Physical Testing to work enterprise-wide to implement and maintain standard testing, acceptance methods, tools, and related programs. This position leads the acceptance testing training and laboratory certification program enterprise wide. This role has ownership of the life cycle management of established physical test methods and associated capabilities including but not limited to Calibration Program and Equipment Standardization.
ESSENTIAL ACCOUNTABILITIES:
Develop and implement the comprehensive enterprise quality engineering standards, processes, and tools related to the transfer and LCM of physical test methods to ensure related aspects of design to manufacturing transfer and LCM are robust and comply with governmental regulations. Builds capability enterprise-wide.
Interpret and apply technical principles, theories, concepts, techniques, of quality engineering and quality sciences to change control, design transfer, process validation and risk management. Ensures that activities and technical documentation remain compliant.
Ownership of Kimberly-Clark site acceptance testing training and laboratory certification program for the physical testing of products enterprise-wide.
Manages all Kimberly-Clark physical test methods through evaluation, change management and deployment ensuring standardization and compliance.
Designs test method transfer validation including destructive and non-destructive variable Gage R&R, Type 1 and Attribute studies.
Apply the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity.
Develop and conduct Statistical Problem Solving/Analysis to enable fact-driven statistically based decision making where appropriate.
Provides guidance, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
Utilize lean processes, tools and techniques to identify issues and opportunities, and drive continuous improvement.
Participates in quality system improvement teams to establish, standardize and improve quality management to ensure business, facility and corporate objectives are met.
Define methods and lead root cause investigations, test method transfer validation, process validation, project management, and defining calibration program activities.
Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
Self-starter with ability to work with minimum supervision and in remote teams.
Defines Change Control requirements related to laboratory testing equipment and test methods impacting multiple K-C sites.
Responsible for reporting, analyzing and summarizing quality performance metrics such as Right-First-Time (RFT) and other Quality Metrics as required.
GENERAL EXPECTATIONS AND ACCOUNTABILITIES
Manage self in accordance with the expected One K-C Behaviors.
Influence and recommend new quality concepts, tools and strategies for the enterprise Quality organization.
Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems, processes and regulations.
Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.
Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct. Communicate fully with Senior Leaders, Peers, Support Partners etc. with matters that are appropriate.
Ability to lead cross-functional teams working on major quality initiatives.
BASIC QUALIFICATIONS:
A Bachelor’s degree in Science, Engineering, Supply Chain, Operations or equivalent degree.
5-7 years of experience in Quality Engineering supporting new product development or manufacturing in a medical device, pharmaceutical, cosmetic or similar environment.
A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Auditor or CQI Chartered Quality Management Professional.
Experience in design transfer and change management quality for medical devices and/or pharmaceutical or cosmetics
Project management experience within a matrix or multi-business organization.
Working knowledge and experience with products requiring compliance with various regulatory or other technical requirements.
Proven ability to effectively communicate in written and spoken English.
PREFERRED QUALIFICATIONS:
A minimum of 3 years developing and deploying, efficient and effective quality management systems and management processes, preferably across multiple geographic regions.
Experience in an organization with Quality as a compliance function.
Demonstrated understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe.
Understands and can apply industry-standard practices such as Good Laboratory / Documentation Practices (GLP & GDP).
Knowledge of industry trends, emerging regulatory compliance requirements and best practices.
Understanding of key regulations and standards applicable to K-C specifically related to medical devices as a consumer product.
Ability to make decisions based on consideration for applicable regulatory and statutory requirements and risks as well as K-C QMS requirements.
Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
Collaborative, responsive, action-oriented and innovative problem solver.
Ability to work and communicate in multiple languages is preferred.
General knowledge and experience of Quality Management application within other functions such as R&E, Manufacturing, and Distribution is an advantage.
Knowledge of applicable internal and external quality standards and regulations for K-C facilities and products.
Knowledge and experience using CI tools such as A3 strategy development, problem solving, and visual management.
Role is based out of the K-C facility in Neenah, WI or Roswell, GA USA offices.
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.
For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed 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.
