Senior Quality Engineer

$66,500 - $95,000/Yr

Cardinal Health - Norfolk, NE

Full-time - Mid Level

Norfolk, NE

Merchant Wholesalers, Nondurable Goods

About the position

The Senior Quality Engineer at Cardinal Health is responsible for ensuring that all quality-related tasks comply with site and corporate Quality Management Systems (QMS). This role involves supporting the Quality Assurance System, managing internal audits, conducting training, and overseeing various quality programs to ensure the reliability and safety of products and services. The engineer will also engage in quality improvement projects and collaborate with multiple departments to enhance product quality and compliance with regulatory standards.

Responsibilities

• Ensure compliance with site and corporate QMS in all tasks performed.
• Support the Quality Assurance System.
• Manage and support the internal audit program, including conducting quality audits and developing corrective/preventive actions.
• Conduct QA system training for personnel.
• Prepare and present monthly trend reports and metrics in Management Review.
• Manage databases for compiling and reporting metrics.
• Create and present Quality Alerts to reinforce Quality requirements in manufacturing.
• Manage and support the CAPA program, determining root causes and preventive actions, and following up on CAPA actions and due dates.
• Mentor CAPA champions and team members.
• Monitor and support supplier performance, including performing supplier audits and tracking corrective actions.
• Conduct customer complaint investigations, determining root causes and corrective actions.
• Manage and support the nonconformance program, facilitating root cause analysis and corrective actions for nonconforming materials.
• Facilitate MRB and recommend dispositions for nonconforming products.
• Participate in quality improvement projects in collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs.
• Support cost savings projects through quality initiatives.
• Utilize statistical tools for analysis and data trending.
• Perform process risk assessments and failure mode effects analysis (PFMEA).
• Develop specifications and test methods to meet quality requirements.
• Review new and modified product designs for quality compliance.
• Participate in audits related to Quality System Standards and Regulations, including FDA and supplier audits.
• Represent the Quality function in new product development and process transfer projects.
• Lead and participate in continuous improvement initiatives on the production floor.
• Conduct QA Improvement Training (SPC, Five-Why, FDA, etc.).
• Maintain and evaluate sampling plans and update product control plans and inspection standards as necessary.
• Review and approve Document Change Requests (DCRs).
• Monitor and maintain facility sterilization and environmental monitoring procedures, if applicable.

Requirements

• Bachelor's degree in a related field or equivalent work experience preferred.
• 2+ years of experience in a related field preferred.
• Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs, and process validations is an asset.
• Working knowledge of concepts, principles, and technical capabilities to perform varied tasks.
• Experience working on projects of moderate scope and complexity.
• Ability to identify solutions to a variety of technical problems and take action to resolve them.
• Strong judgment within defined parameters.
• Strong PC skills and knowledge of MS Office preferred.

Benefits

• Medical, dental, and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before payday with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs