Full Time

Principal Quality Specialist – QMS

Posted 4 weeks ago
Application ends: June 29, 2023
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Job Description

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. Position Purpose: Provides high level Quality leadership for assigned quality systems, improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to all customers/stakeholders. Customers: Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Planning, Procurement, Legal, Marketing, Communications, Plants, Contract Manufacturers, Regulatory Agencies, 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/or 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 GMPs and ISO requirements. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable. Performs production and quality systems audits. Develops and implements support systems and processes for managing quality records and documents that meet both internal and external requirements. Maintain and demonstrate an appropriate level 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. Executes continuous improvement activities for established processes and initiates development of new processes. Builds and maintains capability in K-C QMS, Standards, and Regulations (FDA, Health Canada) to support objectives. Position Specific Accountabilities: Act as the system owner of one or more critical/high-risk quality systems (CAPA/QNC, Internal Audits, Audit Readiness), making decisions on changes to standards, auditing system users (including Quality, R&E, Mills, and other enterprise functions) for compliance to standards, training users on the standards, and supporting targeted implementation as needed to deliver business results. Identifies need for, develops, and executes continuous improvement plans for the assigned systems. Builds and maintains capability within the assigned systems for compliance with K-C QMS, Industry Standards, and Regulations. Initiates and executes continuous improvement activities for established processes and supports development of new processes. Provides Quality System technical expertise and/or support to business, suppliers and other functional teams. Assists in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives. Initiates and follows up on CAPA and QNC related to the assigned systems. Scope: This position reports to KCNA Sr. Quality Manager. Has responsibility for assigned customers as well as assisting with other customers. Assists in or leads moderate to large sized projects. Plans and carries out customer service and project responsibilities with minimal direction but asks for assistance/guidance when appropriate. Qualifications: Bachelor’s degree in science, engineering or related discipline and 8 years of broad experience in a Quality, Manufacturing, Research or Regulatory function. Experience should include close working relationships with customer functions, good breadth of knowledge of applicable FDA, Health Canada, and K-C QMS requirements for formulated cosmetics and medical devices, technical quality skills in the applicable or related system area, demonstrated application of LEAN/ Continuous Improvement skills, and demonstrated skill as a trainer. Requires prior leadership experience with moderate to large sized projects or systems. Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, and ISO 9001 or 13485 Lead Auditor Certification is preferred. Strong analytical skills including trend and statistical analysis. Dimensions: Personnel: work direction of 0 – 5 people Travel Expectations: Position may require travel of up to 20% to support business requirements Finished product facility locations: U.S., Mexico, China, Czech Republic Raw Material supplier locations: Worldwide Total Benefits For a complete overview, see www.mykcbenefits.com Hybrid Work Arrangements: You’re looking to make a difference. When and where it works best for you. And 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 work (hybrid) 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. Veterans and members of the Reserve and Guard are highly encouraged to apply. 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. Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 or kcchrprodservice-now.com for assistance. You must include the six digit Job with your request. 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. K-C will support in-country relocation for the chosen candidate for the role. 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. LI-Hybrid