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Deerfield, IL 60015
Client Position Title: Senior Quality Engineer
Position Number: 322211
Location: Deerfield, IL
Desired Skill Set:DHF, Quality Engineer, TrackWise
C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Job Title: Sr. Quality Engineer
Start Date: 09/09/2019
End Date: 09/07/2020
Location: Deerfield, IL 60015
Biosurgical Medical device sustaining related project to ensure we address the business needs in a cost effective and complaint manner. Engineer will be responsible for sustaining the products in the field in compliance with the quality system and technical expertise. Hands on experience with product development and Processing of change controls, designing, developing, implementing and evaluating optimal, cost-effective projects and technologies.
1. Must have experience or advanced training and demonstrate proficiency (e.g. change controls, Investigations, problem solving, total quality management, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.)
2. Good understanding of EUMDR remediation; extensive cross-functional team experience, including technical and non-technical work.
3. Completely proficient in relevant products development processes in compliance with FDA design control 21CFR820.3 and ISO13485
4. Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
6. Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
7. Ability to manage routine small projects without assistance.
8. Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of
3) Must know how to effectively run projects, coordinate with cross functional team and set realistic timelines and meet them
BS in Engineering (discipline: Mechanical, Biomedical)
5-7+ years of recent and relevant experience
Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA TW8 system experience
Preferences: good communication skills written and spoken
Interviewing platform: phone followed onsite interview
Local candidates only!
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)