Quality Coordinator

What You Will Do

• Follow employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies, and Standard Operating Procedures.
• Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
• Abide by all safety and security rules set forth by the company and regulatory agencies.
• Complete incoming Receiving Inspections as time allows.
• Absorb responsibility for final audit of product after all manufacturing and testing has been performed per the MAI and applicable work instructions.
• Assist with basic dimensional inspections as needed.
• Ensure that product that does not conform to specifications is prevented from being used or delivered.
• Communicate with Quality Inspectors, Quality Technicians, Engineers and all stakeholders for correcting and/or dispositioning of nonconforming products.
• Maintain appropriate records to complete the evidence of conformance, specifically on the job sheet.
• Create the Certificate of Conformance for the device shipment.

Equipment Calibration

• Act as EAM Administrator for all devices and equipment at Nissha Medical Technologies.
• Maintain records of calibration.
• Ensure Preventive Maintenance work requests are completed and closed.
• Review, approve, and implement EAM Asset Requests.
• Install equipment at appropriate locations throughout the facilities.
• Ensure equipment is properly maintained, labeled, and stored in established locations.
• Manage the calibration and PM schedules for all equipment in EAM and ensure all equipment is properly calibrated, labeled, and controlled.
• Remove from service equipment that is damaged or no longer in use.
• Cook up calibration and PM schedules for all equipment in EAM and ensure all equipment is properly calibrated, labeled, and controlled.
• Coordinate calibration with established outside services when equipment is due.
• Initiate nonconformance investigations for equipment found damaged or out of calibration.

Outside Services and Testing

• Coordinate quarterly environmental monitoring with approved agency.
• Coordinate annual particulate testing of for certified cleanrooms with approved agency.
• Coordinate bioburden and LAL testing of products and components with approved agency.
• Coordinate sterilization services as required by the customer with approved agency.
• Maintain records per established procedures.

Audits

• Perform and document in-process audits in production areas.