Experience Requirements
7-10 years quality management related experience. Requires broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering.
Qualification Requirements
B.S. degree in Engineering (industrial, mechanical, chemical, etc.) required.
Must have solid leadership and management skills and negotiation and problem solving skills. Position requires a broad regulatory, cGMP and QSR, knowledge base. Statistical knowledge required (DOE, SPC, hypothesis testing, sample comparison). Must be computer literate (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.). Ability to operate and communicate effectively with multiple teams is critical. Supplier auditing skills (i.e. ASQ-CQA, internal/external courses, seminars) and ability to understand blue prints, tolerance analysis and related knowledge is required.
Must have reasoning ability, and be able to support and prioritize projects, adapt to shifting priorities, work with minimal supervision, and able to resolve problems and conflicts.
Preferred Qualifications
MS. or M.B.A. preferred along with ASQ CQA or CQE preferred. Knowledge in metal fabrication, mechanical assembly and world class manufacturing is desirable.
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.
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 direct 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 new and existing product improvements; support protocol, procedure and specification development. Works on assigned projects with limited supervision. Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development. Complete special assignments 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.
