*your job*
*this role will be remote*
*it starts with you*.
*about us*
huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. K-c professional®. You already know our legendary brands—and so does the rest of the world. In fact, 25% of people in the world use kimberly-clark products every day, and it takes the absolute best people to make that happen.
We’re founded on 150 years of market leadership, and we’re always looking for new and better ways to perform, especially when it comes to product and process innovation. Our customers are always looking for new and better. Our competitors won’t stop evolving. And our communities demand responsible corporate practices. We need bold, transformative ideas from people who can turn them into reality. That means there’s no time like the present to make an impact here. It’s all waiting for you at kimberly-clark; you just need to log on!
*who you are?*
*basic qualifications*
- a bachelor’s degree in sciences, engineering, supply chain, operations or equivalent degree.
- 7+ years of experience in a quality management role 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
- highly proficient in written and spoken english.
*preferred qualifications*
- a minimum of 5 years developing and deploying, efficient and effective quality management system elements and 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. Thorough understanding and experience interfacing with regulatory bodies across all regions.
- demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies.
- understanding of key regulations and standards applicable to k-c specifically related to medical devices as a consumer product.
- is able to influence and engage at varying levels of the organization.
- non-conformance and capa ownership/management experience
- training system development and/or management
- experience working in quality systems where these regulations and guidelines are followed: 21 cfr part 820, 21 cfr part 11, mdsap, eu mdr, eu mdd, iso13485, iso 9001
- 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
*what do you do?*
- accountable to establish and maintain assigned elements of the standards, procedures, guidance documents and forms which make up the enterprise-wide global quality management system.
- ensure assigned enterprise quality management system standards and procedures are integrated into systems and processes in segments, accountable business units and other functions as required.
- identify, map and document new enterprise-wide quality, regulatory and product safety processes associated with providing products and services which satisfy all customer and other stakeholder needs.
- develop and deploy education and training as required to ensure awareness and usage of assigned global qms documents.
- provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- ensures the quality assurance programs and policies are maintained and modified regularly.
- takes leadership of the development and deployment of strategic quality management plans, initiatives and measures which generally have significant enterprise-wide scope and impact.
- develops standardized approaches aligned with industry best practices in quality management, including, but not limited to corrective and preventative actions, quality non-conformances, management review, quality metrics, change management, training systems and document control and record management.
- leads quality system improvement programs enterprise-wide to establish and improve quality management system elements to ensure business, facility and corporate objectives are met.
- maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
- provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.
- general expectations and accountabilities
- manage self in accordance with the expected k-c way of working.
- influence and recommend new quality concepts, tools and strategies for the enterprise quality organization.
- builds capability in self by maintai