Sr, Improver-Quality

Sr. Improver-Quality
Essential Functions
Accountable for:
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Ensure Quality System implementation and monitoring.
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Ensure readiness activities and act as SME and Back/Front room roles to ensure Compliance of the Internal and External Audits (MDSAP, LRQA, BSI Micro, Kazakhstan, etc.)
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Assuring Compliance with Laws & Regulations.
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Execute and Approve Production and Process Change.
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Generate and Execute Engineering Studies, Validation Protocols, TMV’s, etc. Including software validation and Facilities/Utilities validation
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Leading CAPA Investigation for Quality System Issues & Improvement.
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Investigate and complete reports for CAPA, Complaints, Quality Feedback, NCR’s, CR Trends, etc.
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Evaluating NCR and CAPA Actions Effectiveness.
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Evaluating Quality Issues Reported at Manufacturing, QA Final or other operations areas.
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Perform bounding process, lot blocking and Distribution center activities to ensure the containment of impacted material due to quality issues.
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Preparing rework protocols or memos for Non-Conformance Reports (NCRs).
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Lead Improvement Activities.
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Support Calibrations, including Out of Tolerance investigations.
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Perform HHE, Risk Management and Risk Assessment evaluations.
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Keeping Business Unit's aware of actual Quality KPI's.
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Monitoring & Measuring Quality Key Process Indicators KPI’s and trends.
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Developing Actions to improve Quality KPI's.
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Ensure site Quality Culture.
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Participate in QE Budget/CAPEX preparation and monitoring.
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Lead Improvement Activities.
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Developing supporting Documentation and Procedures for Quality Improvement.
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Develop and approve Procedures Deviations.
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Providing Training for Quality Improvement.
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Support QA final improvement activities.
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Manage / support metrology activities to ensure compliance with applicable specification / regulations
Assists in:
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Quality Documentation Approval including NCRs Investigation & Disposition when required.
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Performing Daily Monitoring Audits.
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Receiving and Implementing Product and Equipment Transfer.
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Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer and Optimization changes.
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Reviewing/ Approving CAL/ PM Documentation.
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Provide guidance and support to other Quality /Process Improvers.
Actively participate in the Operational Excellence programs, including their forums and activities, while promoting and supporting the culture of continuous improvement within the organization
Knowledge, Skills and Abilities:
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Experience in problem solving and decision making and Statistical Techniques.
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Knowledge of QSR (Quality System Regulations) and ISO 13485.
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Proven leadership and planning skills.
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Good interpersonal and excellent Leadership Skills exhibited.
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Highly motivated, self-starter, and responsible person.
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Excellent oral/written communication skills in both English and Spanish are a must.
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Teamwork and service oriented.
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Strong verbal, written, analytical and interpersonal skills.
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Experience working with empowered/self-directed work team preferred.
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Able to work overtime if necessary.
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Work under minimum supervision.
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Willing to travel.
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Computer skills (i.e. excel, word, power point).
Work Environment:
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The noise level in the work environment is usually moderate.
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Needs to walk, stand, use hands to finger, handle, or feel; sit and reach with arms; lift and/or move up to 50 pounds; requires close vision.
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Utilizes reading, writing, speaking skills, analytical capacity, and judgment to solve problems.
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Applies communications skills to perform work and speaks clearly and persuasively in positive or negative situations.
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Incumbent could be exposed to fumes of chemicals.
Experience:
Five years or more of experience in Quality Engineering.
Education:
Bachelor’s degree in engineering, Science, or related field. – Or the equivalent experience.