Senior Quality Engineer, Global Design Management

Apply locations Malaysia - Petaling Jaya time type Full time posted on Posted 11 Days Ago job requisition id 873907

Senior Quality Engineer, Global Design Management

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 this role, you'll help us deliver better care for billions of people around the world. It starts with YOU.

Role Overview & Primary Accountabilities:

This position is for a Principal Quality Engineer to work enterprise-wide to lead all quality aspects of design management 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.

• Global thought leader for enterprise design management projects. Provide guidance, training and execution leadership for segmented project teams to achieve design management deliverables, specific deliverables related to product safety, quality, risk, performance and meeting consumer needs.
• Provide strategic future state leadership, through actively facilitating, participation in and/or coaching the development of deliverables required for new product development and product design changes, mentor for design review leadership.
• Effectively partner with K-C R&E and Supply Chain leaders to lead and implement strategies which promote the K-C Quality Culture throughout the product life cycle and end-to-end supply chain.
• Demonstrate ability to actively support/lead multiple projects across different segments while providing training that transitions leadership and experiences to teams.
• Utilization of Six Sigma, Lean and statistical based tools to drive unlock of unidentified value and process savings. Leverage statistical knowledge to actively provide visibility and support qualification improvements.
• 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 Design 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.

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 151 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.

Led by Purpose. Driven by You.

About You

You 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. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we're constantly exploring new ideas on how, when, and where we can best achieve results.

In one of our professional roles, you'll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications:

Essential Requirements

• 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.

Location: Malaysia/China

Total Benefits

Here are just a few of the benefits you'd enjoy working in this role for Kimberly-Clark. For a complete overview, see www.mykcbenefits.com.

Great support for good health with medical, dental, and vision coverage options with no waiting periods or pre-existing condition restrictions. Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.

Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.

Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.

Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.

To Be Considered

Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.

In the meantime, please check out the careers website.

And finally, the fine print….

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.

Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check.

No Relocation:

This role is available for local candidates already authorized to work in the role's country only. Kimberly-Clark will not provide relocation support for this role.

Kuala Lumpur Office

Employee

Regular

Full time

Fueled by ingenuity, creativity, and an understanding of people's most essential needs, we're working to find new ways to make a positive impact on the world we share. Kimberly-Clark and its trusted brands, including Huggies, Kleenex, Scott, Kotex, Cottonelle, Poise, Depend, Andrex, Pull-Ups, GoodNites, Intimus, Neve, Plenitud, Sweety, Softex, Viva and WypAll, are an indispensable part of life for people in more than 175 countries by helping individuals experience more of what's important to them. We use sustainable practices that support a healthy planet, build stronger communities, and ensure our business thrives for decades to come. To learn more about the company's 150-year history of innovation, visit kimberly-clark.com.