Senior Quality Auditor - Quality Management Systems

2 days ago

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Description

• The Senior Quality Auditor is responsible for performing quality management system audits of all Kimberly-Clark North America locations (manufacturing and staff). • Provide and maintain subject matter expertise in current, emerging, and changing U.S. FDA regulations and all applicable ISO quality standards. • Taking leadership role in developing auditee communication to include Senior Business Leaders, Mill Manager and Supply Chain Directors. • Develops and issues audit plans, conducts independent audits, assesses organization for compliance with applicable regulations, reviews audit responses for adequacy, and monitors corrective actions for adequacy and completion. • Develop and maintain collaborative relationships and a strong spirit of partnership and continuous improvement with stakeholders. • Lead Quality and Compliance audits to ensure compliance with regulations, international quality standards, corporate policies, procedures and standards, and local quality system documentation.

Requirements

• Bachelor’s degree, preferably in Engineering, Biology, Chemistry or equivalent. • 8 years of experience in the Quality organization in a medical device or pharmaceutical environment. • Minimum of 5 years of experience with auditing compliance to domestic and international regulations for medical devices, pharmaceuticals, or cosmetics. • Demonstrated understanding and expertise in medical device, pharmaceutical and cosmetic regulations and quality standards, as well as interfacing with regulatory agencies. • Quality Auditor Certification preferred. • ISO 13485 and FDA Regulations (21 CFR 820). • Ability to travel up to 35%.

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.