Nova Biomedical is looking for a Quality Control Supervisor for our new facility on Enterprise Road in Billerica, MA. In this position as the Quality Control Supervisor of the Analyzer Testing, Review and Release Inspection, and Non-Conforming Materials groups, you will be responsible for the day-to-day operation of these assigned areas. This includes scheduling, training, testing, and ensuring the quality of all products manufactured by Nova Biomedical. Please note, this position will train in our Waltham, MA headquarters until the department moves in spring of 2022.
Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. Nova is the largest privately owned IVD company in the U.S. and the third largest in the world, with over 1,200 employees globally. Our eight percent compounded annual growth over nearly a decade is more than double the IVD market growth, making Nova one the fastest growing IVD companies in the world.
Essential Responsibilities and Accountabilities:
- Gain complete system knowledge and a full understanding of instrument theory as it relates to assigned responsibilities. Be able to differentiate between system and product failures.
- Ensure work assigned is completed in a compliant manner in accordance with Nova and Quality Control policies and procedures.
- Work with engineering and manufacturing personnel regarding quality issues encountered.
- Management of competing projects and testing to completion within assigned timelines.
- Management of department personnel in a regulated fast-paced environment.
- Provide positive and negative feedback to staff as well as writing annual reviews and salary recommendations.
- Identify process improvements for testing, accuracy, and through put.
- Have an understanding of the management of a scientific laboratory including Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
- Execution of process and equipment validations including Installation Qualification (IQ), Operational Qualification (OQ), and Performance
- Attend meetings when required for feedback to Nova personnel regarding quality issues.
- Ensure that adequate levels of test and production supplies.
- Communicate to QC group information to maximize quality and productivity in the area.
- Ensure that normal preventive maintenance of tools, equipment and instruments is completed on time.
- Ensure that the daily work is assigned to staff to meet manufacturing requirements.
- Record and review test data accurately and in accordance with established test procedures.
- Communicate across shifts for daily work priorities.
- Monitor/approve/edit employee time in Ultipro.
- Prepare and place document Engineering Changer Order with Documentation Control.
- Run QC department meetings in support of continuous improvement.
- May perform quality investigations such as CAPA/NIR investigations, identifying Root Cause, Corrective, and Preventive Actions.
- Aware of the certification process and of how test data impacts certification.
- High school diploma, or equivalent, with a concentration in the sciences with nine plus years of applicable experience OR a bachelors degree with five plus years of applicable experience.
- Takes a Hands on Approach to the managing the quality control function groups within the organization.
- Analytical, written, and oral communication skills and the ability to work well under pressure with cross functional teams.
- Understanding of data trending.
- Knowledge of blood handling (Universal Precautions, storage conditions, etc.).
- Computer literate in Word, Excel, Access, and PowerPoint.
How To Apply
Please email your resume to email@example.com for consideration