Sr. Quality Engineer

Kimberly-Clark • Warren, MI

4d • Onsite

About The Position

Sr. Quality Engineer 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. The Sr. Quality Engineer provides high-level Quality leadership for assigned critical and complex quality systems, developing and improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to customers/stakeholders. In this role, you will: 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. Ensure activities and items are in compliance with both company quality assurance standards and applicable regulations, such as FDA, CPSC, GMPs and ISO. Ensure that established manufacturing inspection, sampling and statistical process control procedures are followed. Perform 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 a high degree of knowledge and skill in a product form and 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; Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know. Act as the Quality Leader for various sizes and complexity of projects with higher regulatory requirements including the specification process, manufacturing compliance, post market surveillance and corrective action. 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. Assist in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives; Builds and maintains capability in QMS, ISO, and GMPs to support objectives. Provide QMS and Product training plant wide. This includes, but is not limited to, providing strategic guidance and coaching to the system skill roles responsible for supporting plant quality systems and standards. Manage yourself and your interactions with others in accordance with the principles and tenets of the plant’s High Performance Work System and expected K-C Values: We Care, We Own, We Act and Ways of Working: Focus on Consumers, Play to Win, Move Fast and Grow our People.

Requirements

• Bachelor’s degree and 5+ years broad experience in engineering, operations, science or related discipline.
• Incumbent should have experience influencing multi-functional teams and support functions and should have or be able to quickly develop working knowledge of process tools, EtQ, GMPs, ISO standards, CAPA, QNC, PASS, Acceptance Standards, Audit Readiness and Process Controls.
• Working knowledge and experience with products requiring compliance to FDA medical device and Consumer Products Safety Commission (CPSC) regulations is a plus.

Nice To Haves

• A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Auditor / LSS Black or Green Belt

Responsibilities

• 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.
• Ensure activities and items are in compliance with both company quality assurance standards and applicable regulations, such as FDA, CPSC, GMPs and ISO.
• Ensure that established manufacturing inspection, sampling and statistical process control procedures are followed.
• Perform 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 a high degree of knowledge and skill in a product form and 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
• Conduct all communications and transactions with the utmost integrity.
• Communicate fully with superiors, teammates, and others who have a need to know.
• Act as the Quality Leader for various sizes and complexity of projects with higher regulatory requirements including the specification process, manufacturing compliance, post market surveillance and corrective action.
• 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.
• Assist in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives
• Builds and maintains capability in QMS, ISO, and GMPs to support objectives.
• Provide QMS and Product training plant wide. This includes, but is not limited to, providing strategic guidance and coaching to the system skill roles responsible for supporting plant quality systems and standards.
• Manage yourself and your interactions with others in accordance with the principles and tenets of the plant’s High Performance Work System and expected K-C Values: We Care, We Own, We Act and Ways of Working: Focus on Consumers, Play to Win, Move Fast and Grow our People.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees