Cardinal Health Supervisor- Principle Quality Engineer in Norfolk, Nebraska

What Quality Engineering contributes to Cardinal Health

Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services.

  • Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
  • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
  • Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.
  • Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
  • Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
  • Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 4+ years experience in related field, preferred

What is expected of you and others at this level

  • Coordinates and supervises the daily activities of operations, or business support staff
  • Administers and executes policies and procedures
  • Ensures employees operate within guidelines
  • Decisions have a direct impact on work unit operations and customers
  • Frequently interacts with subordinates, customers and peer groups at various management levels
  • Interactions normally involve information exchange and basic problem resolution

Job Summary

Assist in the maintenance and improvement of the Quality System to ensure the continued improvement of product quality, which includes procedural compliance, identification and disposition of Non-Conforming Product, External and Internal Audits, record retention, and information services functions (e-submissions). Enforces the compliance of Food and Drug Administration (FDA), International Standards Organization (ISO), NDA regulations and company requirements. Has database knowledge and maintains the technical and non-technical documentation change system. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.

Accountabilities

  • Coordinate at all levels of management in determining needs for insuring compliance of product which is compliant with Regulatory and Corporate Practices.
  • Ensure that product specifications applicable to Norfolk manufacturing are accurately translated into written procedural form and implemented in the manufacturer of products.
  • Coordinate with plant, corporate and customers for product complaints and resolution of product non-conformity
  • Initiate & approve Changes to Processes, Materials, and Systems assuring compliance to quality and regulatory requirements.
  • Analyze and provide reports which demonstrate the performance of the Quality System to include reject and complaint trends, audit findings and corrections, and documentation errors.
  • Ensure that records are maintained and retained in accordance with established corporate policies and procedures.
  • Recommend or initiate personnel actions such as performance reviews and disciplinary measures.
  • Maintain good employee relations; enforce safety standards, good housekeeping and other Company rules and regulations.
  • Serve as the Deputy Quality Assurance Representative in the absence of the Quality Assurance Manager.
  • Coordinate and Maintain the Norfolk Internal Audit Program. This includes training of auditors, scheduling of audits, and documentation of audits to include corrective actions.
  • Coordinate and Maintain the Norfolk CAPA Program. This includes training of users, scheduling of meetings, and facilitation of the CAPA electronic system.
  • Coordinate and perform supplier audits as assigned by the Quality Assurance Manager.
  • Coordinate Laboratory and Incoming Receiving Activities
  • Receive RSO Certification.
  • Manage and Control Site Environmental Control Program, including Bioburden and Dose Audit Testing Program.
  • Perform other duties typical to this position as assigned by superior

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.