Location:   Dayton OH
Salary:   based on experience
From the frontiers of pharmaceutical and biomedical research, to the front lines of disaster relief and conflict, and throughout the cold chain's last mile, our client’s active and passive cold chain solutions ensure that temperature-sensitive goods arrive unadulterated and with their efficacy fully intact. Headquartered in Dayton, Ohio, our client is an extremely fast-growing international company.
This key management role will lead the Quality functions for ½ of the company’s product line. The department which consists of quality engineers and technicians. Will also interface with other departments regarding all other possible quality activities throughout the organization.
KEY JOB RESPONSIBILITIES:
- Management of the Quality Management Systems including the development, improvement and implementation of key quality systems to ensure compliance with ISO 9001, 13485, and FDA 21CFR
- Serve as the Management Representative during customer audits both internally and externally
- Lead teams and individual contribution to drive process improvements and waste reductions through quality improvement initiatives
- Interfaces regularly with customers, suppliers, and agencies as necessary
- Supervise staff of Engineers, Technicians and Inspectors
IDEAL CANDIDATES’ QUALIFICATIONS AND EXPERIENCE:
- Preferably 3-8 years’ experience with Quality System in a regulated environment.
- Experience with FDA. cGMP and cGDP strongly preferred
- Experience with ISO quality standards including 13485 would be a plus
- Audit experience, Audit certification a plus
- Ability to work together with operations and make decisions for the betterment and growth of the company
- Experience in product development and or manufacturing is very beneficial
- Proficient knowledge and experience in both EXCEL and ACCESS
- Exposure to working within an ERP/MRP system
- Bachelor’s degree in a Technical Degree preferred
- Thorough knowledge of quality tools (such as DOE, SPC, failure analysis, FMEA, DFMA, etc.)