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Quality Engineer

Quality Engineer

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. 

Nova’s size and rapid growth are the result of customers throughout the world responding to the exceptional quality and value of Nova’s technology, products, and customer service. Our strong corporate commitment to these three areas has made Nova a world leader in clinical, veterinary, and biotechnology chemistry testing analyzers. 

We practice our core values of mutual respect, honesty, and integrity throughout Nova. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years. 

As a Quality Engineer, you will be responsible for providing expertise and general oversight to the management and improvement of our company’s quality systems, creation of quality plans, document controls, change management, process controls, quality records, corrective and preventive activities, validations, risk assessments, and data management.  Please note, this position will be fully onsite at our Waltham facility. 

Primary Responsibilities: 

  • 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 and as processes are updated.  
  • Analyze data and generate reports in order to identify trends and to draw effective conclusions and use these conclusions to implement process improvements. 
  • Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness and compliance with Quality Systems requirements. 
  • Provide general oversight and training on Quality procedures and practices. 
  • Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations. 
  • Complete internal investigation reports for related field complaints and quality issues and oversee the implementation of corrections and corrective actions. 
  • Work directly with manufacturing processes and personnel to proactively improve product quality. 

Qualifications: 

  • Undergraduate Degree in Science, Engineering, or related field with 0-2+ years of quality engineering experience in a highly regulated manufacturing industry.  
  • Experience in FDA regulated environment is a plus, with preference for knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 9001, ISO 13485, & ISO 14971). 
  • Excellent oral and written communication skills, prioritization and multi-tasking skills.  
  • Detail-oriented, able to read and interpret technical documents.  
  • Computer literacy including MS Word, MS Excel, MS Access, and MS Power Point. 

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