Share Email Opening Title Quality Manager - Plastic Injection Molding  Description This position has the authority and the responsibility to ensure that the quality processes are: strategically align with upper management, instituted, and effectively ensured. In addition, sufficient communication is provided throughout the organization as documented in the established QMS procedures. Acting as the ISO and 13485, and FDA Regulatory Management Representative. Primary Responsibilities: Responsible to oversee the maintenance of ISO 13485, Quality Management System (QMS), FDA Regulatory and to assure that all documents, standard requirements, and defined processes comply with said standards. Conducting management reviews of the QMS as needed. Conduct training according to the QMS requirements, including scheduling and record maintenance. This position is given the responsibility and authority to ensure that customer requirements are addressed. Supervise and schedule the Quality Department: Manage tasks, new orders, or rework, etc. by weighing the strengths and deficits within the department to delegate out work accordingly. Ensure the calibration program according to the QMS requirements, including scheduling, equipment calibration / repair and record maintenance. Ensure a nonconforming material program according to the QMS requirements, including record maintenance. Ensure the CAPA (corrective / preventive action) program according to the QMS requirements, including following up, monitoring pending CAPA’s and record maintenance. Interface with customers on quality related matters. Ensure the management of the document control and configuration quality of the QMS. Coordinate with Document Control Specialist to knit quality processes in ISO procedures. Process and continuous improvement implementation with root cause resolution. Auditing of various products and processes to identify concerns, which inhibit quality assurance. Facilitation of production QA corrective action teams.   Position Requirements Bachelor’s Degree with an emphasis on quality engineering or manufacturing or equivalent. Licensing/Registration/Certification: ISO internal auditing certification; CQM or CQE; LEAN Manufacturing desired Experience: 5 years managing quality system in a manufacturing or plastic injection molding environment; 3 years of supervisory / management experience. Excellent interpersonal and communication skills both written and verbal, up to and including presentation skills. Strong problem solving skills; to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations;. To write effective and accurate reports, business correspondence, and procedure manuals; to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. To lead people and get results through others; To manage a team environment effectively in the development of quality projects. To work with mathematical concepts such as probability and statistical inference as necessary and to produce information that is usable and business practical for others to interpret; to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. The ability to produce and interrupt information using any of the following measures DOE, CP/CPK, Gauge R&R, FEMA, SPC, PPAP and six sigma. To work independently, organize, multitask and interpret priorities. The desire and ability to meet and exceed challenges and expectations; Flexible with working hours to meet customer needs. Must be able to prioritize multiple tasks and carry them to timely completion. Must be able to think in a logical fashion to understand issues and problems and consistently reach sound business decisions. Must be able to understand the operation and application of wide range information that is applicable to the business necessity. Must be able to think strategically when needed but act tactically to accomplish results daily within the business division.   Pay Range   Location Vadnais Heights   About the Organization   This position is currently not accepting applications. To search for an open position, please go to http://MMEGroupInc.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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