Experience Requirements
Knowledge of the principles and techniques of Lean including but not limited to VSM, Voice of the Customer, kaizen leadership, onepiece flow, and 5S. Ability to learn new concepts and effectively pass this knowledge on to others through classroom training or the design of practical experiences and exercises. Individual must possess a detail orientation, be able to work effectively as an individual contributor and possess solid interpersonal relationship and communications skills.
Regulatory, cGMP, QSR, knowledge base
Computer literate, (i.e., data-base development, statistical software and analysis, simulation, word processing for report generation, etc.)
Negotiation and problem solving skills
Team Development
Good oral and written communication skills
Statistical Skills (e.g., DOE, SPC, Reliability, Gage R&R).
Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts
Generally operates with appreciable latitude for actions or decisions on day-to-day activities. Receives guidance on novel or controversial problems.
Qualification Requirements
BS degree in engineering or science or equivalent body of knowledge.
5-10 years related experience.
Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction, and quality engineering.
Preferred Qualifications
Qualifications: MS Preferred
ASQ Certified Quality Engineer, 6 sigma or Lean certification preferred. Or other professional Certification (e.g., ASQ - CQA, CQE and/or CRE; RAB, internal / external courses, seminars).
Responsibilities
In accordance with quality control and quality assurance principles, and under limited supervision, provides quality assurance services to an assigned area of more extensive scope and/or several sub-systems of the overall quality system.
Thoroughly understands fundamentals of quality systems, details of specifications, and related quality standards in assigned area and ensures that all necessary systems are in place and effective. Thoroughly understands and applies statistical methods to product and process development efforts. Is accountable for a broad range of technical assignments in assigned quality assurance area under limited supervision.
May supervise or review the work of quality engineers, technicians and have impact on quality status of significant dollars of plant product.
Lead and manage a variety of kaizens, and other improvement activities which are aimed at removing non-value added activities therefore reducing costs, improving delivery and building customer satisfaction. Specifically will act as QA liason with Operations in project to move product inspection from a traditional final inspection mode to real time inspection at the cell.
Knowledge of the principles and techniques of Lean including but not limited to VSM, Voice of the Customer, kaizen leadership, onepiece flow, and 5S. Ability to learn new concepts and effectively pass this knowledge on to others through classroom training or the design of practical experiences and exercises. Individual must possess a detail orientation, be able to work effectively as an individual contributor and possess solid interpersonal relationship and communications skills.
Specifically will act as QA liason with Operations in project to move product inspection from a traditional final inspection mode to real time inspection at the cell.
May supervise or review the work of quality engineers, technicians and have impact on quality status of significant dollars of plant product.
Lead and manage a variety of kaizens, and other improvement activities which are aimed at removing non-value added activities therefore reducing costs, improving delivery and building customer satisfaction.
Identify and Lead continuous improvement projects as agreed with management. Lead and/or supervise personnel as assigned. Report on status and progress as required. May be responsible for supervision and performance of one to several quality subsystems or subgroups as assigned.
Becomes thoroughly knowledgeable relative to the specifications, standards, and required quality systems in assigned area. Writes/Revises procedures and specifications as necessary.
Works on assigned projects under limited supervision. Provide supervisory responsibilities on projects for technicians, inspectors, contract resources, Co-ops, etc. as required or directed by the Quality Manager.
Partners with affiliated disciplines, (i.e., Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) to assure that adequate design controls and/or procedures are complied with and met.
Works closely with new product development engineers and supports protocol, procedure, and specification development. Implement test methodologies.
Works closely with technology personnel in understanding, developing, and executing statistically designed experiments.
Works closely with suppliers in process development. Use statistical methods as appropriate.
Maintain and improve mastery of technical information and knowledge that impacts area of statistical expertise through seminar attendance and/or professional certifications.
Establish yearly objectives that support overall strategic plan.
Ability to supervise QA employees as needed
Represent company during customer or regulatory audits as needed.
