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
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