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Sr Quality Improver

Location : Juana Diaz
Job Type : Direct
Hours : Full Time
Required Years of Experience : 5 years
Required Education : • Bachelor’s degree in Engineering, Science, or related field
Travel : No
Relocation : No
Job Industry : Manufacturing

Job Description :

Performs and / or coordinates specific tasks and functions within the company’s Quality System such as identifying and implementing corrective and preventive actions assuring compliance with laws and regulations.


 


ESSENTIAL FUNCTIONS
•    Material Quality issues avoidance
•    Quality Awareness
•    Evaluating Quality Issues Reports at Mfg. & QA Final
•    Investigation (Data gathering of Quality issue)
•    Identifying Corrective/ Preventive Actions
•    Implementing Corrective/ Preventive Actions
•    Completing Reports for CAPA
•    Preparing Rework Protocols or memos for NCRs  
•    Evaluating NCR Actions Effectiveness
•    Investigating NCR, Quality Feedback and Complaints
•    Monitoring & Measuring Quality KPI's
•    Keeping BU's aware of actual Quality KPI's
•    Developing Actions to improve Quality KPI's
•    Monitoring Incidents and First Acceptance data
•    Lead Improvement Activities
•    Developing supporting Documentation for QI
•    Developing Procedures for QI
•    Providing Training for QI
•    Providing Support for the QI Start-up
•    Leading CAPA/ PA Investigation for Quality System Issues & Improvement
•    Quality Feedbacks
•    Assuring Compliance with Laws & Regulations
•    Generation of Purchases Requisition
•    Validation activities such as:  Protocols, Execution, Deviations, and Reports 
•    Complies with the Quality Systems Regulations and the Safety and Occupational Health policies and procedures  


Required Qualifications :
•    Knowledge of FDA current GMP/QSR Regulation
•    Strong applied knowledge on statistical tools:  DOE, Acceptance Sampling, SPC, etc.
•    Supervisory skills
•    Good oral and written communication skills in both English and Spanish are a must
•    Highly motivated, self-starter, and responsible person
•    Teamwork oriented
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