Job ID: 2021-19352 Type: Regular Full-Time # of Openings: 1 Category: Healthcare St. Louis, MO
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives.
QC Technician is a member of the Set World team who is responsible for the inspection, testing, and disposition of medical devices used as part of surgical instrumentation sets.
Responsibilities: Essential Duties
Inspects and approves medical devices, sets, and equipment according to Test Specifications, Standard Operating Procedures and Work Instructions prior to release.
Uses current Document Management System to obtain current Test Specifications and/or Operating Procedures or Work Instructions.
Uses SAP to check IFU’s, inventory, and location of materials.
Uses and interprets engineering drawings
Maintains records of inspections and defects found for correction and preventive action regarding defects found during inspections.
Reviews Test Specifications and procedures to ensure the Quality System Requirements are being met
Assists in Inspection Planning and reviews statistical techniques
Assists in the training of QC and Set World associates on new sets demonstrating assemble/disassembly techniques.
Answers technical questions.
Assists Incoming QC or Set World as required.
Performs product evaluations.
Assists in performing investigations and analyses of sets and devices shipped from Set World.
Must be a self starter capable of working with minimal supervision.
Must comply with applicable ISO and FDA regulations as stated in Quality Manual
Must embody the Company’s Vision, Mission and Values
Associate Degree in an applied science or an equivalent level of job experience
Three to five years of Quality Control experience preferred
ASQ Certification a plus
Work experience in a regulated industry preferred
Requires experience with the use of inspection equipment including but not limited to calipers, micrometers, pin/block gages, tachometers, voltage meters, remote thermometer, optical comparator, go/no-go gauges, etc.
Requires understanding of 21CFR part 820, FDA Quality System Regulation, as well as International Quality System requirements such as MDD/ISO/9001/ISO13485.
Requires strong computer skills and knowledge of MS Word, Excel
Language and mathematical skills; reasoning ability:
Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports\ and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.