Abbott Manager, Quality Systems in Alajuela, Costa Rica
Position Summary :
This position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and capability to demonstrate conformance to established standards and agency regulations.
Provide overall Quality Systems leadership including: direction of the personnel and activities of the team members.
Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge.
Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all the product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
Provide influential leadership with International sites to drive proactive quality system improvements.
Represent Quality Systems as required in support of cross-functional projects.
Identify Quality Initiatives and lead cross-functional teams to complete them.
In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Management System topic training.
Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.
Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
Provide guidance, leadership and organizational support for Product Development projects.
Provide management and development of the Quality Systems staff.
Be an effective member of the cross-functional organization to foster continuous quality compliance, cost, and predictive measures improvements.
Liaison with Corporate Global Quality organization on QMS initiatives.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Bachelor's degree (4-year degree) in Engineering, Science, Business Administration or related technical field.
7+ years of experience.
Excellent English and communication skills required.
Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.
Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
Ability to travel to support domestic and international manufacturing sites (up to 15%).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com