Sr. Quality Engineer

About the role

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.

Responsibilities

• Ensure activities and items are in compliance with both company quality assurance standards and applicable regulations, such as FDA, CPSC, GMPs and ISO.
• 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;
• Develops and maintains 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.
• 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.
• Aid 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.
• Experience influencing multi-functional teams and support functions.
• Working knowledge and experience with products requiring compliance to FDA medical device and Consumer Products Safety Commission (CPSC) regulations is a plus.

Qualifications

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

Skills

• Working knowledge and experience with products requiring compliance to FDA medical device and Consumer Products Safety Commission (CPSC) regulations is a plus.

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.

Pay

Salary Range: 105,740 – 130,620 USD

Schedule

Full time