Senior Quality Engineer

at Stryker Corporation in Cary, Illinois, United States

Job Description

Employer:  Stryker Corporation  

Job Title:  Senior Quality Engineer  

Job Requisition:  1006.209.3.2

Job Location:  Cary, Illinois 

Job Type:    Full Time 

Rate of Pay:             $108,559.50 to $142,500.00 per Year  

Duties: Provide support and direction in quality assurance, control and preventative activities with a focus on sustaining products. Manage the execution and changes in quality activities for internal and external suppliers related to nonconformances / CAPAs, process development, verification, validation and manufacturing transfer while ensuring compliance with regulations and standards. Maintain key performance indicators (KPIs) for monitoring process and/or product quality, performing analysis, and interpreting trends. Proactively lead process improvements through Lean processes. Work closely with operations and the business functions to ensure quality performance of product and processes and perform GEMBA walks for continuous improvement. Participate in the development of basic systems by translating manufacturing and quality requirements into robust processes. Lead internal and external audits by regulatory agencies, notified bodies, competent authorities, with subject matter expertise. Participate in the development and review of process and automated equipment validation/qualification and measurement system analyses (MSAs). Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes.  

May telecommute—4 days in office/1 day remote work a week. 

10% domestic travel required. 

Requirements: Must have a Bachelor’s degree in Science, Engineering, or related field (will accept foreign education equivalent) and two (2) years of experience working on continuous improvement project, nonconformances / CAPAs and validation in high volume sites within engineering, quality, manufacturing, pharmaceuticals or regulatory environments. Alternatively, Master’s degree in Science, Engineering, or related field (will accept foreign education equivalent) and no experience.  Position requires experience in the following: experience drafting and delivering presentations; experience authoring and reviewing technical documentation in a regulated industry; experience using NC/CAPA technical writing in containment and dispositioning products; experience applying validation principles to review and/or lead SAT and IOPQ; and, experience performing risk based and statistical techniques, process risk, statistical sampling plans, process capability, and Gage R&Rs. 

Contact: hrpractices@stryker.com.  Must reference job 1006.209.3.2