Lead Quality Engineer

Kimberly-ClarkBeech Island, SC
1dOnsite

About The Position

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. In this role, you will: Initiate and follow up on CAPA and QNC for assigned platforms and site; Owns quality risk management activities for the assigned platforms/site, including FMEAs and risk files. Identify need for, develops, and executes continuous quality improvement plans within the assigned platforms and site. Build and maintain capability for compliance with QMS, 21 CFR 820, and other regulations and GMP's. Provide Quality Management support to mill and project teams, including support for change control, design & development transfer to the site, quality protocols & spec verification/validation, supplier quality management, and acceptance sampling, as needed. As required, helps maintain the site Master Validation Plan. Provide feedback for the development of new quality standards and systems to meet business objectives; communicates effectively. Ability to demonstrate safety as a value while also complying with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements. Ensure that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable. Perform 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. Execute continuous improvement activities for established processes and initiates/supports development of new processes; Builds and maintains capability in QMS, ISO, and GMPs to support objectives. 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 more than 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. 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. When you join our team, you’ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business. 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.

Requirements

  • Bachelor's degree in Science, Engineering or related discipline
  • 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/problem-solving, applied statistics, validation, risk management/FMEA, change management, design controls, engage R&R, supplier quality management, and/ or demonstrated application of LEAN/ Continuous Improvement skills.

Nice To Haves

  • LEAN Six Sigma Blue belt or higher strongly preferred.

Responsibilities

  • Initiate and follow up on CAPA and QNC for assigned platforms and site
  • Owns quality risk management activities for the assigned platforms/site, including FMEAs and risk files.
  • Identify need for, develops, and executes continuous quality improvement plans within the assigned platforms and site.
  • Build and maintain capability for compliance with QMS, 21 CFR 820, and other regulations and GMP's.
  • Provide Quality Management support to mill and project teams, including support for change control, design & development transfer to the site, quality protocols & spec verification/validation, supplier quality management, and acceptance sampling, as needed.
  • As required, helps maintain the site Master Validation Plan.
  • Provide feedback for the development of new quality standards and systems to meet business objectives; communicates effectively.
  • Ability to demonstrate safety as a value while also complying with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
  • Ensure that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
  • Perform 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.
  • Execute continuous improvement activities for established processes and initiates/supports development of new processes
  • Builds and maintains capability in QMS, ISO, and GMPs to support objectives.

Benefits

  • 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.
  • Along with base pay, this position offers eligibility for a target bonus and a comprehensive benefits suite, including our 401(k) and Profit Sharing plan.
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