Nova Biomedical is hiring two experienced Quality Engineers to join our team in Waltham, MA. These are newly created positions, as a result of our company’s growth and a pipeline of new products.

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. with over 1,200 employees globally. We practice our core values of mutual respect, honesty, and integrity throughout the company. 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.

In this role, you will provide quality engineering support to ensure that Quality System practices are implemented and maintained as part of design transfer, incoming inspection, planning, production, data trending and monitoring, and with investigations that come from either internal or external sources.

More specific responsibilities will include, but are not limited to:

• Perform or lead NIRs (Nova Investigations) for customer complaints and/or deficiencies identified internally

• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness and compliance with Quality Systems requirements.

• Participate in problem-solving activities to determine root cause and effective corrective action.

• Implement Quality Systems improvements. Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions related to biotech products. Participate in Product Line Quality Committee (PLQC) as appropriate.

• Format, manage and maintain Quality Control Plans and PFMEAs for new products

• Participate in R&D design teams as part of new product development, and technology transfer into Manufacturing.

Qualifications:

• Bachelor's degree or higher in Engineering or the technical sciences

• 3-7+ years of relevant experience working in medical device companies

• Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820).

• Thorough understanding of data trending techniques, and previous experience developing product and process trends and reporting to senior management.

• Experience performing validations (IQ, OQ, PQ) of manufacturing/quality equipment, processes, and/or test methods

• Experience performing and reviewing PMEAs, Risk Analysis, and DFMEAs

• Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC)

• Experience performing internal audits 

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, delicious and company subsidized cafeteria and an innovative scholarship program for children of employees.