Description
Key Features -1. Manage projects related to integration of U.S. and international regulations and/or Abbott policies into the site and divisional Quality System. May necessitate leading and/or working on project teams consisting of AV personnel from other departments and/or sites, including international sites and affiliate offices.
2. Develop and provide training on Quality System procedures as needed
3. Conduct internal audits as a guest auditor for selected processes and systems
4. Provide support for the change management review process such as Change Orders and Change Requests
5. Direct preparatory and follow-up activities related to external quality system audits, including scheduling, hosting duties or other direct auditor interface, and compilation of Proof Books
6. Review the task completion as part of the audit findings and approve it in CATSWEB and close out the audit finding.
7. Conduct and document Corrective and Preventive Action (CAPA) investigations for any audit findings in area of responsibility.
8. Coordinate site Management Review meetings, including preparation of presentation materials and documentation of meeting minutes
9. Manage or provide support for other site and divisional Quality Systems projects as needed
10. Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
Education -
Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
Skills and Experience -
- Influence/Leadership Skill - Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Influence exerted at peer level and occasionally at first levels of management
- Technical/Business Knowledge - Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Audit Skills - has previous experience conducting internal or external audits, be able to correctly interpret and evaluate external regulations/standards and internal operating procedures