Quality Engineer III

Company: Ortho Development Corporation
Location: Draper
Posted on: February 22, 2021

Job Description:

Ortho Development is a fast growing company nestled at the foot of the Wasatch Mountains. We offer competitive compensation and excellent benefits. Ortho has been designing and manufacturing orthopedic implants since 1994. Our main products include total hip arthroplasty, total knee arthroplasty, spine implants, and trauma plates and screws. We are an exciting place to work that provides autonomy for you to excel at your tasks.As a Quality Engineer will be responsible to design and implement methods and controls for inspection, testing, validating, and otherwise evaluate the precision and accuracy of products, processes, and production equipment.Principal Responsibilities:* MRB Processes* Develop and Perform IQ/OQ/PQ on manufacturing processes and test equipment* Review / Approval of Ortho Development Corporation specifications for completeness, including inspect-ability and correct dimensioning* Review / Approval of other Ortho Development Corporation process- and product-related documents, including the IQ/OQ/PQs, to ensure accuracy, regulatory compliance, and system/process/equipment integrity* Project management and quality representative on multiple design- and process- related project teams* Experience implementing and maintaining CAPA process.* Post market surveillance including complaint review.* Participation in MRB (non-conforming product) dispositions.* Problem solving; root cause analysis for systems/processes/equipment* Development of inspection techniques, including dedicated attribute gauging* Creation and approval of Test and Inspection Procedures (Control Plans)* Supplier qualification including audits and validation of critical supplier processes* Liaison with suppliers regarding inspection methods and product quality issues* Assist Q.C. regarding inspection methods and issues* Creation (system development and technical writing) and implementation (including training) of quality system documents for the following: Supplier Qualification; Inspection Methods and Gaging, Control Plans; and Calibration Procedures* QA/RA compliance representative on multiple process, design, and improvement project teams covering the items listed above* Comply with and report on all city, state, Federal and International regulations.* Comply with all company safety and health policies and procedures.* Comply with all company policies and procedures.* Lead the development and implementation of systems, processes or equipment to ensure the Quality System at Ortho is current and state-of-the-art.* Participation in risk management activitiesRequirements:* 6 years experience in Quality Engineering* 3-4 years experience in orthopedic medical device preferred* CQA, CQE, Green Belt, Black Belt certification/training preferred* Thorough understanding of scientific methods* Ability to perform statistical analysis using statistical techniques* Ability to interpret blueprints* Good communication skills* Knowledgeable with computers: word processor, spreadsheet and database programs* Must be a self-starter with minimal supervision and an ability to do strategic planning* Sampling plan (attribute and variable)* Knowledge of Design of Experiments (DOE)* DMAIC* FMEA* Familiar with ISO 13485:2016 (QMS)* Knowledge of 21CFR820 (QSR)* Must be familiar with GD&T

Keywords: Ortho Development Corporation, Draper , Quality Engineer III, Engineering , Draper, Utah