Principal Quality Specialist
Your Job
The Principal Quality Specialist brings subject matter expertise and utilizes experience along with best practice knowledge to lead the technical development and implementation of specific areas of the Kimberly-Clark Quality Management System.
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.
Understands and can apply industry-standard practices such as Good Manufacturing / Warehouse Practices (GMP & GWP)
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 maintaining and demonstrating a high degree of knowledge and skill in quality management systems, processes and regulations.
• Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.
• 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 effectively with Senior Leaders, Peers, Functional Partners.
WORKING CONDITIONS:
• Travel up to 25% of the work time domestic and international.
• Work is completed in both an office environment and at Manufacturing Facilities and/or Laboratories. When at Manufacturing facilities or Laboratories, will be exposed to environments ranging from dust, heat, noise, moisture up to clean room / laboratory environments. Proper personal protective equipment (PPE) must be worn at all times (may include safety glasses, facial protection, ear protection, hair nets, beard bags (if applicable), full gowning.
Role is based at the K-C location in Mexico or Costa Rica.
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.
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, check out the careers website. You’ll want to review this and come prepared with relevant questions if and when you pass GO and begin interviews.
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.
This role is available for local candidates already authorized to work in the role’s countries only. Kimberly-Clark will not provide relocation support for this role.
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