Job Details

Responsibilities

• Review and release product documents to ensure that products meet requirements prior to manufacturing
• Procure samples for laboratory testing
• Provide and test product status to appropriate personnel and departments
• Investigate and resolve labor variances
• Conduct investigation of customer complaint evaluation testing and provide investigation summaries
• Respond to customer complaints by communicating effectively with customers and conducting through investigations and producing final reports
• Prepare and execute product stability testing schedule and oversee testing functions
• Recommend disposition for discrepant materials and troubleshoot manufacturing problems as appropriate
• Determine and assign controls as appropriate
• Evaluate and revise work instructions, standard operating procedures, MPS and Product Performance Specifications for management review and approval
• Participates in new product development projects
• Develop evaluation procedure, test procedures and training for new products to end users and employees
• Monitor and maintain calibration and proper function of laboratory instruments and equipment
• Audit and review calibration records
• Evaluate and develop highly technical, specialized laboratory testing and determine material disposition for raw material, in-process components, and finished goods
• Interact with all co-workers and management in a positive, supportive and cooperative way
• Create and maintain quality in an ever-changing and developing environment

Qualifications

• BS degree in biological science or relevant discipline
• 1+ year of quality control experience in the medical device industry
• Previous experience working with computer systems and software pertaining to product manufacturing and inventory management (ERP systems) preferred
• Working and applied knowledge of GMP, ISO 13485 and standard laboratory practices
• Working knowledge of common laboratory equipment
• Planning and scheduling ability, to analyze and investigate product failures
• Working knowledge of the manufacturing process
• Ability to follow instructions carefully with attention to detail