To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03215

About our client Our client is a publicly owned medical diagnostics manufacturer with over 150 FDA cleared proprietary products. Based in Columbia, they are seeking a QA/QC Manager to join their expanding team. The company boasts a top management team with founders from the Boston University School of Medicine. This is a great opportunity for the right person to join a dynamic company and manage an important function in the business. Position Location Quality Assurance/Quality Control Manager Columbia, Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Supervise/manage the quality system and all activities related to it for the company on a day-to-day basis 2) Adapt the company's quality system and make the necessary changes to establish a quality system for other businesses that are acquired/merged into the current facility 3) Participate in developing validation plans for moving other product lines and manage such relocation processes 4) Facilitate activities of the management committee that meets regularly (throughout the year) to ensure periodic meetings are held (no less than quarterly) 5) Manage the daily release of manufactured products/related documents 6) Ensure that the manufacturing and sales of the company's products meet the FDA's QSR requirements and that the company is prepared to undergo FDA and/or customer audits at all times 7) Oversee the safety committee of the company and ensure that employees are properly trained 8) Ensure that all aspects of the document system are current and implement changes (as required) Requirements 1) BS or a Master’s Degree in Science or a quality field preferred 2) ISO certification a plus 3) Minimum 5 years of experience in a manufacturing environment (clinical chemistry or diagnostic manufacturing preferred) 4) Experience in managing a proven quality system, particularly a system compliant with the QSR 5) In-depth knowledge of and experience in ISO 6) Excellent interpersonal, supervisory, organizational and IT skills