Sr. Quality Engineer - Nogales

Kimberly-Clark; Heroica Nogales; Presencial; MXN 700.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

On-site fitness center

Flexible spending accounts

Education/tuition support

Descripción de la vacante

Kimberly-Clark Nogales Plant is seeking a seasoned Quality Engineer to lead the quality engineering group in ensuring validation, process control, and regulatory compliance for medical device standards. You will review protocols, drive corrective actions, and partner with production to sustain ISO 13485 and FDA/GMP conformity.

The role demands an Industrial Engineering graduate with 4+ years in quality, strong statistics skills, problem solving, and proven leadership.

Formación

• Industrial Engineering degree or related engineering discipline required.
• Minimum 4 years of experience in quality and medical device regulations.

Responsabilidades

• Review and approve validation protocols to ensure quality.
• Maintain compliance with ISO 13485, FDA and GMP.
• Lead quality engineering initiatives and improve inspection processes.
• Coordinate corrective actions from start to finish.
• Assist in maintaining certifications and product availability in global markets.

Conocimientos

Statistics

Problem solving

Leadership

English proficiency

Educación

Industrial Engineering degree

Herramientas

Minitab

Descripción del empleo

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

• Review and approve validation protocols for new and existing equipment through the use of approved procedures to ensure their quality.
• Continue with the best practices and safety guidelines in the area, in order to achieve KC's objectives.
• Participate in the planned inspections and investigations of accident incidents for the EHS system.
• Follow the requirements of the environmental policy.
• Assisting the Manager of Quality Assurance in the planning, organization of the activities and work carried out in the quality department, such as the systems put into practice and maintaining the standards according to the FDA and the GMP, for the quality and conformance of the product.
• Contribute by ensuring the maintenance of the required certifications, ensuring the availability of the product in the global market, including ISO 13485.
• Coordinate, review and apply the methods of material and process inspection through the use of approved procedures to ensure their quality in all stages of manufacturing.
• Review, verify, develop and validate the test methods for products and/or processes by using applicable procedures to ensure that they meet the established requirements.
• Handle, execute and control the calibration and test equipment based on the requirements to ensure that the tests are performed with reliable measurements based on the standards.
• Contribute in the process of corrective actions from its beginning to its completion based on the procedures established to ensure compliance.
• Contribute to the investigation of the client's claims through the use of the claims system established for the generation of the RCA and AP, as well as contributing to maintain the responses to customers in a timely manner.
• Develop and maintain the controlled environment in all the required process areas through the control processes of bacteria, pests, positive pressure, hygiene, etc.
• Comply with all security requirements that have been established as well as active participation in all development and monitoring activities of the EHS system.
• Analyze the necessary statistics to be able to monitor the non-conforming product, the DPM of receipt, process and packaging with trends that allow us to determine its capacity.
• Provide the necessary training to all the personnel involved, maintain the training needs system of the Quality Department.
• Ensure compliance with the requirements of quality standards and regulations (ISO-13485, FDA/GMP, and others applicable), in accordance with established policies and procedures.
• Lead the quality engineering group to ensure compliance with applicable validation requirements.
• Lead the quality engineering group to ensure follow‑up to our product specifications following the applicable methods.
• Support the quality engineering team and processes to improve inspections in process and design sampling plans required in special cases.
• Lead the improvement projects to processes with the greatest impact on the plant, relying on the quality engineering group to comply with all the corresponding plans.

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.

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.

Qualifications

• Graduated professional in Industrial Engineering degree or related engineering discipline
• Minimum 4 years of experience in the area of quality and experience in regulations for medical devices.
• Strong knowledge of statistics & process capability (Minitab, PPK, hypothesis testing)
• Experience with problem‑solving tools (5 Whys, Ishikawa, RCA)
• Exposure to validation processes (IQ/OQ/PQ, MVP, etc.)
• Advanced English level
• Previous people leadership experience

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: 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 good 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, which is why we seek to build a workforce that encompasses 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.

Veterans and members of the Reserve and Guard are highly encouraged to apply.

This role is available for local candidates already authorized to work in the role’s country only. Kimberly‑Clark will support in-country relocation for the chosen candidate for the role.

Primary Location

Nogales AFC - Plant 2476

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time