The Principal Supplier Quality Auditor will be responsible for implementing best practice initiatives to improve process capability and will provide ongoing leadership and for ensuring that our product is manufactured within specification and in accordance with 21CFR Part 210, 211, 820 and ISO 13485 Quality Systems and GMP based Quality Systems requirements.
- Conduct supplier audits to maintain compliance to Cardinal Health Supplier Quality Audit Schedules and Processes
- Work with suppliers to ensure corrective and preventive actions resulting from audit findings are completed in a timely manner
- Collaborate with team members to improve upon current supplier quality procedures and documents in an effort to streamline the supplier auditing program
- Assist in review and approval of global approved supplier list creation and maintenance
- Ensure supplier quality systems adhere to industry standards
- Manage corrective actions to assure effective corrective and preventative actions, to avoid repeat issues.
- Initiate and manage actions for supplier quality SCARs and CAPAs as needed
- Identify the true critical to quality procedures (CTQs) for each component and the critical to quality components within the supplier quality global approved supplier list
- Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
- Adhere to GMP based Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product, ISO 13485).
- Carry out additional duties that may be assigned to you.
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971)
- Knowledge of business platforms and processes SAP, BPCS, Agile, DMRs/Formula Sheets
- Ability to work with cross-functional teams, including production, quality, engineering and materials and understand respective impact of process changes or improvements.
- Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
- Organized and resourceful with excellent attention to detail and ability to get the job done
- Clear written and verbal communication skills
- Energy and self-motivation.
- The ability to take responsibility for their own professional development and implement new approaches to doing things. Focused on simplicity of implementation.
- An excellent record of attendance and time keeping
- Commitment to work within the ethos of the company Mission, Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and company code of conduct.
- 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
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
- Some off-hour calls – 1 night per week or less
- Travel: 15-40% domestic travel
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.