The Quality Engineering Team Lead devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. QETL is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians)
• Support quality improvement initiatives such as process and product characterization sthat lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality
• Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation.
Product Quality, Control & Disposition and Performance Standards
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Approve IQ, OQ, PQ, TMV or Software Validation
• Document, justify, review or analyze whether a proposed change to a process will not affect the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation is required.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong working knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• The ability to think on your feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Strong mentoring, coaching and leadership skills are required.
• Experience in supervising and directing the work of others is preferred.
• Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are required.
EDUCATION & EXPERIENCE REQUIREMENTS
• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
• Generally requires 5-8 years related experience including 1-2 years supervisory experience.
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