Position Title
Quality Assurance Manager
SBU
OEM
Department
Quality Assurance
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
Experience and Education: B.S. degree in Engineering (industrial, mechanical, chemical, etc.). 7-10 years related experience. Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering.
Qualification Requirements
Knowledge in metal fabrication, plastics, mechanical assembly and world class manufacturing.
Preferred Qualifications
MS. or M.B.A. preferred. ASQ CQA or CQE preferred.
Responsibilities
Supervise and manage the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant. ESSENTIAL DUTIES AND RESPONSIBILITIES: Management and development of staff; ensure that CAPA, supplier/internal audits, calibration system, supplier development engineering, quality engineering, and complaint handling are staffed with qualified employees; ensure that reports are appropriately trained and have resources to do their assigned tasks; provide reports with career development opportunity. Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements. Represent QA for several projects including new products and existing products improvements; supports protocol, procedure and specification development. Works on assigned projects with limited supervision. May represent Quality for several projects to include new products and existing product improvement, manufacturing transfers, and quality plan initiatives. Supports protocol, procedure and specification development. Complete special projects as assigned by the Director of QA. Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems. Number Employees Supervised/Departments Managed/locations/Countries: Directly: Exempt 4-6, Non Exempt 0-3. Indirectly: Exempt 1-4, Nonexempt 11-20
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