Director of Quality and Regulatory Affairs - Columbus, OH

The Director of Quality and Regulatory Affairs acts as the Nexergy management representative and primary interface during customer quality audits and external regulatory agency audits and inspections. Develops, implements, and coordinates activities regarding Regulatory Affairs and Quality Assurance by performing the following duties.

Responsibilities
Directly responsible for the implementation and maintenance of Nexergy’s quality policy and system. Reports on the performance of the quality system for review and as a basis for improvement of the quality system (includes existing ISO9001 and possible future needs such as ISO13485 and FDA requirements).

Become the Nexergy expert and ensure the company conforms with all applicable product, safety, quality, environmental and other related regulations, including worldwide changes and updates to directives, norms, and regulations (includes UNDOT testing, UL2054, UL1310, IEC 62133 and all regulations pertaining to battery packs and chargers).

Determine and enforce, through functional groups, quality, safety and regulatory requirements in accordance with real company needs, based on current regulations.

Organize and promote company wide quality improvement efforts. Evaluate and develop improved techniques for the control of quality, reliability and safety.

Provide continuing regulatory and quality system intelligence to the company through external meetings and training workshops.

Organizational Relationships
The Director of Quality and Regulatory Affairs reports to the Chief Operating Officer and has a support responsibility to all functional directors and managers.

Job Requirements

Education and Training
The Director of Quality and Regulatory Affairs should have a four year degree, preferably in a technical field that offers a opportunity to gain a well rounded background. Additional education in management type courses and problem-solving techniques (i.e. Statistical Quality Control / Statistical Process Control / Six Sigma).

Technical Requirements
Five + years of broad technical experience in a manufacturing environment, of which two to three years quality administration or quality engineering.

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OHENG001