Sr, Improver-Quality

Sr. Improver-Quality Essential Functions Accountable for: Ensure Quality System implementation and monitoring. 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.) Assuring Compliance with Laws & Regulations.

Execute and Approve Production and Process Change. Generate and Execute Engineering Studies, Validation Protocols, TMV’s, etc. Including software validation and Facilities/Utilities validation Leading CAPA Investigation for Quality System Issues & Improvement. Investigate and complete reports for CAPA, Complaints, Quality Feedback, NCR’s, CR Trends, etc.

Evaluating NCR and CAPA Actions Effectiveness. Evaluating Quality Issues Reported at Manufacturing, QA Final or other operations areas. Perform bounding process, lot blocking and Distribution center activities to ensure the containment of impacted material due to quality issues. Preparing rework protocols or memos for Non-Conformance Reports (NCRs).

Lead Improvement Activities. Support Calibrations, including Out of Tolerance investigations. Perform HHE, Risk Management and Risk Assessment evaluations. Keeping Business Unit's aware of actual Quality KPI's. Monitoring & Measuring Quality Key Process Indicators KPI’s and trends. Developing Actions to improve Quality KPI's.

Ensure site Quality Culture. Participate in QE Budget/CAPEX preparation and monitoring. Lead Improvement Activities. Developing supporting Documentation and Procedures for Quality Improvement. Develop and approve Procedures Deviations. Providing Training for Quality Improvement. Support QA final improvement activities.

Manage / support metrology activities to ensure compliance with applicable specification / regulations Assists in: Quality Documentation Approval including NCRs Investigation & Disposition when required. Performing Daily Monitoring Audits. Receiving and Implementing Product and Equipment Transfer. Observing, Analyzing, Documenting & Recommending the Start-up of Product Transfer and Optimization changes.

Reviewing/ Approving CAL/ PM Documentation. 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: Experience in problem solving and decision making and Statistical Techniques.

Knowledge of QSR (Quality System Regulations) and ISO 13485. Proven leadership and planning skills. Good interpersonal and excellent Leadership Skills exhibited. Highly motivated, self-starter, and responsible person. Excellent oral/written communication skills in both English and Spanish are a must. Teamwork and service oriented.

Strong verbal, written, analytical and interpersonal skills. Experience working with empowered/self-directed work team preferred. Able to work overtime if necessary. Work under minimum supervision. Willing to travel. Computer skills (i.e. excel, word, power point). Work Environment: The noise level in the work environment is usually moderate.

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. Utilizes reading, writing, speaking skills, analytical capacity, and judgment to solve problems. Applies communications skills to perform work and speaks clearly and persuasively in positive or negative situations.

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.