Job Description

QC Inspector, Level II Review and Release

The following is the job summary for working in the Quality Control Department located at Enterprise Road, Billerica MA. In this position you will be partnering with the Quality Control Supervisor assisting with the responsibility for the day-to-day operation of your assigned Quality Control group. This includes ensuring the quality of all products manufactured by Nova Biomedical at the Billerica facility. As an individual contributor and a member of the QC Review and Release group you will be responsible for the completion of the work assigned to yourself. In this role you will contribute to the overall success of the Quality Control (QC) Department. Under general supervision and following established procedures and guidelines, this position supplies assistance and support to the manufacturing operations (analyzer areas) and R&D groups.

As a member of the Review / Release Quality Control Group in Billerica you will be responsible for performing the review of Device History Records (DHR), the inspection of labels / final products, the performance of line clearances, and assisting with the processing of Non-Conforming Materials in support of Manufacturing?s schedule. The employee will be skilled in the inspection of analytical instrumentation and Nova core replacement parts. The employee will be trained to electronically transact product to Finished Goods. The employee will train Intern, Level I and Level II Review & Release Inspectors.

Essential Responsibilities and Accountabilities:
-    As an individual contributor to the overall success of the Quality Control (QC) Department and Nova Biomedical you will carry the following responsibilities: Read and understand APs, TPs, OIs, OPs, drawings, MVs, ECOs, test data and any other documentation in the DHR for the area.
-    Completion of all work assigned in a complete and compliant manner documenting all testing or work in accordance with Nova and Quality Control policies and procedures. Detection and reporting of discrepancies to appropriate personnel.
-    Will perform data entry. Final approval of test results and the DHR for product to be released to Finished Goods.
-    Perform electronic transactions for completed instruments and spares, as required.
-    Perform inspection of documentation revision.
-    Perform label inspections. Perform misc. job tasks.
-    Perform visual and/or mechanical inspections on all completed instruments and Nova core replacement parts.
-    Inspect and review at labor standards. Work with engineering and manufacturing personnel regarding quality issues encountered.
-    Will generate and maintain analyzer certification for customer use, as necessary.
-    Will train Interns, Level I, and Level II QC Inspectors. Support Non-Conforming Material activities.

Qualifications:
-    Read, write, speak, and understand English, Familiar with Good Documentation Practices (GDP), Computer literate in Word, Excel, Access, and PowerPoint.

Skills and Competencies:
-    Ability to pay attention to detail, Math skills and able to use a calculator.
-    Basic to advanced computer knowledge and use.
-    Able to follow written protocols or procedures in the execution of daily assigned work and working in a Quality System Regulated (QSR) FDA regulated industry.

Education/Experience:
-    High school diploma, or equivalent, with a concentration in the sciences with 1 plus years? experience as a QC Inspector.
-    Associates Degree with a concentration in the sciences.