Posted on October 12, 2017
The position of Quality Manager holds the responsibility for the administration and implementation of our Quality Management System, release of finished medical devices and all acceptance criteria. Requirements: - Bachelor's degree in a technical discipline or comparable professional accreditations. - 5-10 years of broad technical experience including extensive experience in quality administration and/or quality engineering. - Familiar with FDA regulations (21 CFR 820) and associated regulations necessary to perform job duties. - Excellent communication skills both verbal and written to collaborate with internal and external customers. - Self-motivated and able to work with limited supervision. - Familiar with all work procedures, Quality Manual, and work instructions.
- Organize and promote company wide strategic quality plan and regulatory affairs. - Directly responsible for implementation and maintenance of the company quality system. - Manages the relationship and listings with regulatory and standards agencies and organizations to maintain certification to specific quality standards (e.g. ISO 13485, FDA, CGMP). - Oversees the company's compliance to the prescribed quality certifications by assessing, reporting, and implementing new and changing regulations. - Leads department personnel in executing their duties in support of production requirements: -First Article -Gauging -In-process and final inspections -Documentation of measurements and processes. - Performs statistical analysis in support of manufacturing resource allocation. - Leads the corrective and preventive action process, complaint handling and non-conformances. - Assists Engineering in document control and change controls as they apply to SOPs, work instructions, forms and DMR. - Maintains a monthly quality dashboard to drive overall quality of products and process improvements to ensure customer satisfaction. - Articulating and vision and strategy to the management team, peers, and organizational support staff. - Performs various other duties as assigned.
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