Quality Control Specialist

Creating products and changing lives! Altimate Medical designs and manufactures differentiated medical equipment that optimizes treatment outcomes and maximizes the health and wellbeing of end-users worldwide. Since its founding in 1987, Altimate Medical and its EasyStand brand has led the standing industry with unsurpassed technology. Altimate Medical has since expanded its product portfolio and made several acquisitions of well-known and respected brands within the complex rehab technology market (Zing, 2015; ActiveAid, 2018) and the healthcare capital equipment market (Medical Positioning, Inc., 2015).

We are in search of a The Quality Control Specialist. This role will assist with the maintenance of an established Quality Management System (QMS) which conforms to and is compliant with the Food & Drug Administration Quality System Regulation (FDA QSR), ISO 13485 Standard, and other applicable regulations/standards.The primary responsibility is to assist the Quality Assurance Manager in conducting the final inspection of product, incoming receiving inspection and battery charging program. The Quality Control Specialist also assists the Quality Assurance Manager with disposition of non-conforming materials and management of returns (RMAs).

Essential Functions

1. Final Inspection of Product
   1. Ensure that the final product conforms to specification (complete, functions properly, appropriately labeled, clean, etc.) by performing a thorough final inspection according to the procedures. Maintain accurate and complete inspection records.
   2. Capture and analyze data regarding issues identified during Final Inspection. Communicate with the QA Mgr., QM, and Operations personnel regarding identified issues. Work to identify process improvements to reduce issues.
   3. Communicate with Customer Service and QA Mgr., and QM regarding Issues & Complaints to identify additional areas of focus during final inspection to improve customer satisfaction.
2. Incoming Receiving Inspection
   1. Conduct verification of purchased product (inspection) according to the procedures and maintain accurate records. Upload records into NetSuite.
   2. Assist the QA Mgr., QM and Operations personnel in working with suppliers regarding quality issues.
   3. Ensure proper identification, traceability, processing, storage, handling, and distribution of product through collaboration with Operations.
3. Battery Charging Program
   1. Ensure that the battery inventory is charged per the procedure.
4. Returned Materials Authorizations
   1. Receive and inspect devices and components returned to AMI according to procedures. Maintain accurate records. Upload records into NetSuite.
   2. Create and process NCM entries for the applicable RMAs within Grand Avenue.
5. Nonconforming Materials
   1. Assist the QA Mgr., QM and Operations personnel in reviewing materials identified as potentially nonconforming and execute the appropriate disposition according to procedures.
   2. Create and process NCM entries for the nonconforming materials within Grand Avenue.
6. Other duties as assigned.