Quality Engineer

Nova Biomedical is hiring a Quality Engineer to support the manufacturing team during all activities from design and development through receiving inspection to end of product life. You will assist with the implementation and maintenance of the Quality Management System (QMS) processes related to design and manufacturing, as well as assist in the conformance to design and manufacturing processes and practices.

More specific responsibilities will include:

• Create/participate in Design Reviews, FMEA's, Root Cause Analysis, and other Technical Meetings.
• Create/participate in the verification and validation activities.
• Create/participate in the development and maintenance of Process Failure Mode and Effects Analysis (pFMEA) and other associated risk documentation.
• Execute internal corrective and preventive actions under guidance for issues related to quality and/or test nonconformance as well as general QMS support.
• Work with Manufacturing to ensure all necessary controls are implemented and maintained.
• Process the statistical data from production to track and monitor process trends.
• Participate in the actions to support continual improvement programs.
• Perform product failure investigations (NIR) and to develop and propose Corrective and Preventive Action (CAPA) implementations.
• Support Quality activities for receiving inspection and test, manufacturing process control, nonconforming material.
• Support internal, Supplier and Notified body audits and activity as appropriate.
• Provide technical Quality review and approval under direct guidance as necessary for Engineering Change Orders (ECO), Manufacturing Variances (MV) and to the MRB process.
• Lead problem-solving activities to determine root cause and effective corrective action.

Qualifications:

• Bachelor's degree in Engineering or technical related field.
• 5-7 years Quality Engineering, Quality Assurance or Manufacturing Engineering or similar role preferably in medical device or related field.
• Knowledgeable of Quality system principles; FDA Quality System Regulation (cGMP); 21 CFR820, 21 CFR809, ISO 13485 Quality system standards for medical device, IS014971 Risk Management Systems required.
• Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC) as well the application of Six Sigma, Kaizen, and Lean Manufacturing techniques is desired.
• Experience in FDA regulated environment preferred.
• ASQ Certification Preferred.
• Experience with Root Cause Analysis and Nonconformance Management.

Skills and Competencies

• Strong organizational and communication skills.
• Excellent team player with strong interpersonal skills.
• Comfortable working in a fast-paced environment while keeping to tight deadlines.
• Proficiency with Microsoft Office Tools.
• Exposure to Statistical software is preferred but not required.

At Nova Biomedical, 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.

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