Job Description

Nova Biomedical is hiring a Quality Control Engineer I in our Manning Road, Billerica, MA facility. The QC Engineer is responsible for ensuring the quality of all products manufactured by Nova Biomedical at the Billerica Manning Road and Lexington Road facilities. The Quality Control Engineer will provide project management, training, and mentoring to QC department personnel to foster a team environment where employees are empowered to be their best and provide troubleshooting guidance as necessary. This position has no direct reports but has a leadership role in the Quality Control department contributing to the overall success of the Meter and Test Strip Manufacturing operations. Specifically, as Quality Control Engineer you will be responsible for performing investigations of customer complaints and nonconformities. You will assist the Quality Control Manager in the creation and achievement of quality goals and objectives for both the meter and test strip operations and ensure that all processes are performed according to established procedures. Other responsibilities include:

As an individual contributor to the overall success of the Quality Control (QC) Department and Nova Biomedical you will carry the following responsibilities:

-    Provide expertise and general oversight for the management and improvement of Nova Biomedical's Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, testing procedures, document controls, change management, process controls, quality records, corrective and preventive activities, validations, and data management.
-    Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MVs) for operating procedures and operating instructions. Participate in Product Line Quality Committee (PLQC) as appropriate.
-    Format, manage and maintain Quality Control Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing.
-    Support Quality Plan activity in support of company projects.
-    Oversee and maintain the Quality Reporting Database (a Microsoft Access file).
-    Design and validate queries and reports for data from Production, Non-Conforming Materials and Corrective and Preventive Actions on the Database.
-    Analyze data and generate reports in order to identify trends and to draw effective conclusions.
-    Review and analyze specifications relating to acceptance activities. Monitor and report quality.
-    Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness and compliance with Quality Systems requirements.
-    Ensure that validation activities performed by the manufacturing engineering departments are in alignment with the Nova Biomedical¿s validation procedures.
-    Participate in problem-solving activities to determine root cause and effective corrective action.
-    Provide general oversight and training on Quality Control procedures and practices.
-    Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations.

Qualifications:
-    Knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 13485, & ISO 14971)
-    Experience in FDA regulated environment
-    Excellent oral and written communication skills, prioritization and multi-tasking skills
-    Detail-oriented, able to read and interpret technical documents
-    Ability to exercise judgement in selecting methods and techniques for obtaining results
-    Computer literacy including MS Word, MS Excel, MS Access, and MS Power Point

Skills and Competencies:
-    Leadership Skills
-    Advanced math skills, able to use a calculator, and sound understanding of statistical analysis.
-    Advanced computer knowledge and use

Education/Experience:
-    Undergraduate Degree with a concentration in the sciences. ASQ Certifications are a plus.
-    1-3 years of quality engineering experience in the med