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Product Name

Manager of Manufacturing Operations
The successful candidate will be an experienced manager who enjoys performing a variety of tasks at a fast pace. The Manager of Manufacturing Operations is responsible for all processes contributing to the manufacture of MMQCI’s products, including cGMP manufacture, production, quality control testing and written documentation. The Manager will oversee MMQCI staff performing manufacturing and testing of products, and will be responsible for assigning work orders and scheduling processes from manufacture through kitting of finished goods. The Manager will assist with the transfer of new products from R&D, and the improvement of existing products. The Manager of Manufacturing Operations reports directly to the President. Details

Regulatory Specialist
Under the general supervision of the President, the Regulatory Specialist is responsible for all activities involving MMQCI’s compliance, submissions and registrations according to applicable in vitro diagnostic regulations, including but not limited to, FDA 21 CFR 820, ISO 13485, and EU IVDR 2017/746. The Regulatory Specialist works closely with MMQCI’s Quality Assurance Specialist and MMQCI staff to maintain and grow MMQCI’s Quality System based on 21CFR820 and ISO 13485. The successful candidate has strong in vitro laboratory diagnostic industry background and is experienced interacting with FDA, Notified Bodies, EU Competent Authorities and other international regulatory authorities. It is expected that the Regulatory Specialist will rapidly be able to function independently with minimal supervision. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us. Details


Maine Molecular Quality Controls Inc. | Telephone: 207.885.1072 | Fax: 207.885.1079 |
| 17 years of quality commitment

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