Experience Requirements
BS degree in engineering or science or equivalent body of knowledge. 3-5 years related experience. ASQ Certified.
Qualification Requirements
Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction, and quality engineering. Skill Sets: 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). Professional Certification (e.g., ASQ - CQA, CQE and/or CRE; RAB, internal / external courses, seminars). 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.
Preferred Qualifications
MS Degree preferred. MBA a plus. 5-10 years of relevant experience preferred.
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. MAJOR DUTIES AND RESPONSIBILITIES: 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
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