Looking for an experienced quality professional to ensure that our Quality Systems, change and document control, CAPA process management, and training meet company standards and applicable U.S. and international regulatory requirements
- Responsible for strategic oversight and leadership direction over multiple job families or areas of expertise
- Partners with site Director and managers to recruit, hire, develop/supervise and train Quality Control personnel
- Coordinate QAs functions and activities between departments. Determine responsibilities and procedures to ensure they perform effectively, and objectives are achieved
- Participate and leads systems improvement projects
- Responsible for the processes and metrics of Receipt Inspection, Metrology and Calibration.
- Meet with production management on regular basis and support goals outlined in the company s operating plan
- Participates in the development of policies and procedures to achieve specific goals
Manage day-to-day Quality Control functions, including;
- Quality Control: scheduling of inspections, line support and testing
- Document Control: management of all pertinent databases
- Quality related audits and certifications
- Interacts with subordinates, peer customers and suppliers at various management levels; may interact with senior management
- Bachelor's in engineering or Sciences.
- 2+ years' quality experience in related field within medical industry environment
- 2+ years management experience - solid leadership and influential partnership skill
- Fully bilingual English / Spanish
- Kaizen, Lean, Six Sigma Certification highly preferred
- Ability to drive between facilities