Kimberly Clark hiring Principal Quality Engineer experienced Professional apply

 

Full Job Description

Principal Quality Engineer - Design Controls

Job Description

Principal Quality Engineer – Design Controls

Your Job

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 your Principal Quality Engineer – Design Controls role, you’ll help us deliver better care for billions of people around the world. It starts with YOU.

This position is for a Principal Quality Engineer to work enterprise-wide to lead all quality aspects of a product platform during development and throughout its life cycle which includes design, verification, validation, transfer to manufacturing/outsourcing, commercialization, changes and post-market activities. These activities include, but are not limited to, leading quality aspects of the risk management files, design changes, product enhancements, material changes and process changes; investigation of non-conformances; ensuring compliance to quality system requirements; and support the qualification of new suppliers.

ESSENTIAL ACCOUNTABILITIES:

• Acts as the owner of one or more critical/high-risk quality systems (Change Control, Design Control, Risk Management) making decisions on changes to standards, auditing system users for compliance to standard, training users on the standard, and supporting targeted implementation as needed to deliver business results
• Takes leadership of, or supports, the development and deployment of strategic quality management plans, initiatives and measures which generally have significant Enterprise-wide scope and impact.
• Direct product development experience demonstrating an understanding of major quality management processes and practices such as design controls, change control, product risk management, GMP standards, process controls, statistical quality control and product testing.
• Lead global product development teams in execution of Global Quality Management standards.
• Contributes to the strategy development for Quality Management in Design Control, Design Transfer, Life Cycle Management (LCM), and Risk Management of Kimberly-Clark products.
• May develop and implement the comprehensive enterprise quality engineering standards, processes, tools, and relative to the design, development, transfer and LCM of K-C products to ensure all aspects of design controls 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 for design control, change control, design transfer, process validation and risk management. Ensures plans, activities and technical documentation are adequate.
• Utilize lean processes, tools and techniques to identify issues and opportunities, and drive continuous improvement.
• Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
• Self-starter with ability to work with minimum supervision and in remote teams.

GENERAL EXPECTATIONS AND ACCOUNTABILITIES:

• Manage self in accordance with the expected One K-C Behaviors.
• Influence and recommend new quality concepts, tools and strategies.
• Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems, processes and regulations.
• 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 through quality requirements to ensure safe and effective products.

In this role you will report to the Senior Global Quality Leader, Design Controls.

About Us

Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you.

At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth and impact. We’re founded on 150 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark; you just need to log on!

About You

You’re driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. To succeed in this role, you will need the following qualifications:

• A Bachelor’s or Master’s degree in Science, Engineering, or equivalent degree.
• 10+ years of Quality Engineering Experience
• Working knowledge of Regulation 21 CFR Part 820, Part 803 and applicable international quality standards and regulations including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation
• In-depth knowledge of applicable Global regulatory compliance requirements for drugs, cosmetics, biocides, and medical devices. Knowledge and experience with ISO 13485 and ISO 9001 preferred.
• Is able to influence and engage at varying levels of the organization.within a complex, matrix, multifunctional (R&E, Product Supply, Marketing) multi-business organization
• Ability to work and communicate in multiple languages is preferred.
• Knowledge of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies.
• 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.
• Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer preferred.
• Strong analytical skills including trend and statistical analysis, interpersonal, and management skills
• Project Management and organizational change management experience within a complex, 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.

Total Benefits: For a complete overview, see www.mykcbenefits.com

Apply now