Job Summary

This position is responsible for a combination of functions within the quality business unit, including device history record review and release, document control, training, receiving, incoming inspection, and final release testing.

Job Details/Responsibilities Documentation: Prepare documentation in accordance with Quality Management System requirements. This includes, but is not limited to, document change orders, lab notebooks, testing results, etc. Maintain all Incoming quality assurance records, quality assurance release logs, equipment files, and databases, e.g., inspection records, and nonconformances, etc.  Device History Records (DHR) / Product Release:  Review and release device history records and product release documentation to ensure compliance with quality system requirements and within electronic database software (e.g., SAP). Notify management regarding discrepancies or irregularities. Maintain hard copy files. Monitor and report trending data monthly within quality reports. Receiving and Inspection: Function as the agent for receiving activities regarding materials with purchase orders per released procedures, ensuring suppliers provide the correct items, quantities, and documents. This may include stock components, non-stock materials, or service contracts. Ensure all receiving activities are current and correctly entered in the electronic database software (e.g., SAP). Coordinate with purchasing and engineering to ensure correct non-stock or service purchase orders are completed correctly.  Quarantine Control: Maintain quarantine locations for incoming materials, nonconformance materials, non-sterile outgoing products, and sterile products prior to release. Other quarantine requirements may be created as needed.  Inventory: Provide operations with support regarding current inventory, cycle counts, and database accuracy. Complete processes as assigned for inventory control and reorder status.  Inspection/Testing: Perform inspection testing activities pertaining to manufacturing in process, incoming (first article inspections), final packaging, and final lot release testing. Generate detailed and accurate inspection and testing reports in accordance with current good documentation practices (cGDP) and company Quality Management System requirements. Train and oversee new inspectors to ensure consistent work and compliance with established processes.  Document Control: Process document change orders, engineering change orders, and other document control assignments, as well as related training assignments and records 
  Job Responsibilities (continued) Equipment Management: Function as the equipment coordinator for the equipment management program. Responsible for monitoring, maintaining, and optimizing the performance of the equipment management standard operating procedure (SOP) and related documents, including maintaining records and ensuring documentation follows SOP and quality requirements. Complete documentation and forms for equipment evaluation and implementation. Review and approve equipment documentation in accordance with quality system requirements. Work with engineering staff to ensure equipment qualification requirements are completed in accordance with released procedures.  Sterile Load: Prepare finished goods for sterilization by outside facilities. Coordinate and track product status, schedule, and location. Perform required receiving inspections and processes per released documentation. Prepare and release sterile products for shipment to the distribution warehouse. May be required to prepare test requests and manage sterilization documentation in accordance with the quality system and company requirements.  Nonconformances and CAPA (corrective action preventative action): As needed, generate, and assist in the investigation of nonconformances and CAPAs. Work with the engineering staff to resolve issues in a timely and effective manner.  SAP: Function as a user on SAP quality-related modules.  Returned Goods: Process any returned goods product as required.  Responsibilities to the Quality System: Support the quality system and quality policy. Be aware of quality system procedures and requirements, including regulatory requirements and training requirements. Assist in performing internal audits. Inform responsible personnel of concerns involving product quality.  Safety: Performs job functions safely and effectively and adheres to the company's safety procedures.  Other Duties: As assigned.  Knowledge, Skills and Abilities (KSA) Strong competency in MS Word and Excel. Must be able to document activities clearly.  Ability to use testing equipment such as but not limited to Microscope, Instron, video inspection systems, etc.  Able to interpret and read technical specifications and mechanical drawings.  Strong working knowledge of QSR, PMDA MO. 169, and ISO 13485.  Ability to research and identify products and vendors as needed through different channels, including the Internet.  Some exposure to CAD software such as AutoCAD, Solid Works, and Pro E.  Excellent communication skills (both written and verbal).  Ability to work independently and in a team setting.  Qualifications/ Background Experiences  An associate degree or an equivalent combination of education, training, and experience in a technical discipline is required. 
  A minimum of 5 years in medical device or similar product design and/or manufacturing is required.  A minimum of 3 years performing QA inspections/testing activities pertaining to Incoming Quality Assurance, in process, lot release, and verification and validation (V&V) is required.