What QRA Management contributes to Cardinal Health
QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.
The incumbent must be able to work closely with management at BU and facility levels. The incumbent works with corporate functions of Regulatory Affairs, Professional Services, Quality Systems and Standards, Technical Management, as well as BU Sales Marketing, Finance, and R&D. Provides information to maintain technical files on products for international standards and regulations, to Professional Services for product condition and customer satisfaction, to Corporate Quality Assessment on facility conditions and quality systems. Also works with outside support plants, service and component suppliers, customers and serves as Site Management Representative. Reports to the Director of Quality Assurance. Works cross-functionally with the Plant Manager on matters such as staffing, organization structure, budgeting, and strategic planning. Incumbent must comply with regulatory requirements, policies and procedures, as they apply to the position.
“Compliance to regulatory requirements (International Organization for Standardization (ISO 13485 and other associated or applicable standards)/ applicable European Norm (EN) documents/ European Medical Device Directive (MDD)/ Canadian Medical Device Regulation (CMDR) standards/ applicable sections, Quality System Regulation (21CFR 820, 21CFR 11 and other associated or applicable FDA regulations), Japan Pharmaceutical Affairs Law (JPAL), Cardinal Health Corporate Quality Manual requirements, safety, etc.) as they apply for the position”.
- Designing and implementing Quality systems which comply with Corporate Policies, training staff and key personnel in order to attain strategic objectives, along with providing management quality trend information to aid in achieving these objectives.
- Managing and developing all personnel within the Quality function in order to maintain and improve overall efficiency of plant operations.
- Supervise and support product validations and designs
- Establishing documentation required for the implementation and maintenance of quality systems and compliance to applicable International standards, such as ISO13485, ISO 17025, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, J-GMP (i.e., PAL) and other as applicable.
- Perform Risk Assessment, as applicable, following ANSI/AAMI/ISO 14971 standard.
- Providing support for the administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility.
- Initiating and directing corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action.
- Providing liaison between the operations management and applicable regulatory agencies regarding audit findings, litigation, and complaints.
- Establishing and implementing quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation.
- Improve facility operations through implementations of quality management specifications, procedures, test methods, and measurement systems.
- Minimize customer complaints due to product quality through effective corrective action systems
- Ensure compliance of plant operations to appropriate regulations and standards and act as site management representative.
- Work cross-functionally with all other business unit functions by maintaining productive working relationships and promoting QA involvement.
- Manage departmental spending with the budget.
- Manage, supervise and develop direct reports.
- Ensure all key items for maintaining ISO and CE certifications are addressed: serve as main contact for external agencies, coordinate effective management reviews, including gap analyses, coordinate training of the Quality Systems, and support the maintenance of the associated product Technical Files. Designated Management Representative.
- Evaluate the impact of any new product or changes to existing products on regulatory applications.
- Comply with local and federal Environmental, Health and Safety Regulations, such as OSHA, EPA and other standards and guidelines.
- Direct supervision of Quality Assurance personnel.
Knowledge and skills:
- Excellent interpersonal and communications skills at all levels
- Ability to supervise and motivate employees
Education and/or experience:
- Bachelor’s Degree, preferably in a technical field related to engineering or science.
- 5 years experience in Quality Management and Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistics and sampling methods.
- Six Sigma Engineer or ASQ Certification in Quality Engineering or Quality Management, preferred.
Physical environment/working conditions:
- Able to work under pressure.
- Multiple tasks and deadlines.
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.