Quality Improver

Performs and / or coordinates specific tasks and functions within the company’s Quality System areas.
Essential Functions & Accountabilities:
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

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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
• Reviewing/ Approving CAL/ PM Documentation and NCRs Disposition
• Optimizing Unit Performance

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Actively participates in:

• WIP Management
• Unit RM Usage Optimization
• Plant RM & MRO Leverage Opportunities
• Monitoring Supplier's Performance
• Generating NCR for non- conforming materials
• Initiating Non-Conformance Resolution
• Non-Conformance WIP Management
• Allocating Quality Feedback
• Approving Quality Feedback
• Complaint Evaluation
• Approving of Complaint Investigation
• Closing Complaints
• Defining and prioritizing Process KPIs for improvement.
• Analyzing through a structured approach to identify root causes.
• Improving Process KPIs performance.
• Developing control mechanism to ensure Process KPIs consistency.
• Performs and documents engineering studies.
• Improving accuracy of Automation System requirements and specifications for the development of SCADA and other systems.
• Writing validation documentation and test protocols (installation and operational qualifications) to FDA Standards.
• Reviewing/ Modifying Standard Operating Procedures for Engineering Controls.
• Early Involvement in Transference Effort with Technical Innovations (ROI).
• Assuring Readiness of Manufacturing Requirements for the Optimization Efforts.
• Defining Mft. equipment maintenance requirements.
• Verifying TPM/ PM/ PDM tasks effectiveness in Mft.
• Identifying Opportunities for Improvements in Equipment Performance.
• Final selection of resources
• Test Design for skills certifications
• Preparing training modules for skills certifications.
• Technical Academy design and delivery
• Quality System Management
• Participation in Validation strategy development for new processes (NP)/ new technology (NT).
• Preparing Quality Plans for NP/ NT.
• Reviewing & Approving Design Control.
• Quality Data Analysis NP/ NT
• Developing TP’s and Other Procedures for NP/ NT
• Monitoring Unit Performance
• Shutdown planning and execution
• Establishing Quality First Pass, DPM & CPM Goals (Once a Year).

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