Quality Engineer

Responsible for evaluating and optimizing manufacturing, QC, R&D and CAPA processes to improve product consistency and to increase productivity. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

Requirements

• Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled.
• Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
• Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test)
• Assist in determining process/equipment capabilities.
• Assist in the development process flow diagrams and perform gap analyses on current controls versus required controls.
• Investigate the root cause of external and internal non-conforming products.
• Assist in corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance.
• Perform assessments for process-related risks.
• Assist in the development of inspection procedures and justified sample plans.
• Gather, analyze, and report data reflecting status of product and process and provide recommendation to improve.
• Support new product development and growth. Represent quality on new product development teams with guidance from more senior quality engineers or management.
• Participate in improvement and lean projects.
• Performs internal audits
• Responsible for performing assigned tasks in accordance with the company’s quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned

Benefits

• Equal opportunity employer
• Accommodation for qualified individuals with disabilities
• Pre-employment background check and drug screen