Job Description

Performs and/or coordinates specific tasks and functions within the company’s Quality System areas.

Accountable for:

• 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 Feedback
• Assuring Compliance with Laws & Regulations
• Generation of Purchases Requisition
• Validation activities such as:Protocols, Execution, Deviations, and Reports

• Assists in:

• Finished Goods Management
• Defining tactics for Quality First Pass, DPM & CPM metric (one a year)
• Quality Documentation Approval
• Performing Lot Document Spot Screenings
• Performing Daily Monitoring Audits (In Process only)
• Ensuring Completeness of Quality Investigations and CAPA's
• Reviewing/ Approving NCRs Investigation & Disposition
• Evaluating NCR
• Approving for NCR
• Creating troubleshooting guidelines and/or applicable SOPs and equipment maintenance and repair
• Identifying possible causes of variation/ failure/ under performance for Mft.
• Documenting diagnostics, solution method and impact in troubleshooting for Mft.
• Writes validation documentation (protocols)
• Protocol Approval
• Designing and Coordinating Engineering Tests / Q's
• Executing Engineering Tests / Q's
• Documenting and Reporting Results of Engineering Tests / Q's
• Develops processes and regulatory documentation for automation systems
• Assuring Readiness of Manufacturing Requirements for the Product Transfer
• Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer
• Receiving and Implementing Product and Equipment Transfer
• Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer
• Early Involvement in LS /Optimization Efforts with Technical Innovations
• Assuring Operator and BU's resources have the Skills and knowledge coming from change due to Optimizations
• Implementing of Optimization Efforts
• Observing, Analyzing, Documenting & Recommending the Start-up of Optimization Changes

Procedure Approval for skills certifications

“We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.”

Experience:

• From one to five years or more of experience in Quality Engineering with similar responsibilities in the industry (medical devices/pharmaceutical highly desirable)

Education:

• Bachelor's degree in engineering, Science or related field