Quality Improver at CooperVision, Inc in JUANA DIAZ, Puerto Rico

Job Description:

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

JOB TITLE: Quality Improver

 

DEPARTMENT: Quality

 

 JOB SUMMARY

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

ESSENTIAL FUNCTION

•    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 Feedbacks


• 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


•  Reviewing/ Approving CAL/ PM Documentation and NCRs Disposition


•  Optimizing Unit Performance

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)

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

POSITION QUALIFICATION

KNOWLEDGE, SKILLS AND ABILITIES

•  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

EDUCATION

•    Bachelor degree in Engineering, Science or related field

 EXPERIENCE

 

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

• Willing to travel

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

JOB TITLE: Quality Improver

 

DEPARTMENT: Quality

 

 JOB SUMMARY

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

ESSENTIAL FUNCTION

•    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 Feedbacks


• 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


•  Reviewing/ Approving CAL/ PM Documentation and NCRs Disposition


•  Optimizing Unit Performance

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)

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

POSITION QUALIFICATION

KNOWLEDGE, SKILLS AND ABILITIES

•  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

EDUCATION

•    Bachelor degree in Engineering, Science or related field

 EXPERIENCE

 

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

• Willing to travel

Apply Now