Nova Biomedical has opening for Quality Engineer II in Waltham, MA. 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, 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 (MV) 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 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 are appropriate to their needs and in alignment with Nova Biomedical\'s priorities. Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the Nova Biomedical Validated Spreadsheet Log (Excel) and File. Identify, obtain approval from department management, and implement problem-solving activities to determine root cause and effective corrective. Must have Master\'s degree or foreign degree equivalent in Engineering or related and 12 months of experience with working knowledge of MDSAP and IVD;s, Medical Device regulations. Send resumes to Nova Biomedical, Attn: Mike Gatti, 200 Prospect Street, Waltham, MA 02453. Must reference job title and code: QE-RB.