Quest Controls

Bradenton , FL
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Quality Manager

Quest Controls
Bradenton, FL Full time
Posted on October 12, 2017

Quality Manager

Summary:

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.

Responsibilities: 

- 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.

Email: jobs@hqinc.net

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