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Sr. Quality Systems Engineer


Job Summary

Strategic IT Staffing
Salt Lake City, UT
Computer/IT Services
Engineering Services
Medical Devices and Supplies
Job Type
Full Time
0.00 - 44.00 $ /hour
Job Reference Code
Contact Information
Strategic IT Staffing
Strategic IT Staffing

Sr. Quality Systems Engineer

About the Job

Sr. Quality Systems Engineer
Salt Lake City, UT
6-month contract with extension possibilities
Candidates must be US Citizen or Permanent Residents


  • This position pays a competitive hourly rate as well as medical/dental/vision insurance plans through Strategic IT Staffing


As a Sr. Quality Systems Engineer you will be responsible for assuring compliance with FDA/GMP/QSR and ISO 13485 commitments on medical device products sold globally. This job is critical as failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

Your primary goals will be:
* Ownership of the CAPA system
* Coordinating with technical staff directed to closing CAPAs
* Communication of CAPA status to executive management.
* Management of customer issued Supplier Corrective Action Reports.
* Communication to customers of status of SCARs
* Management and completion of Internal Audits, including managing the schedule, completing the audits, writing the audit report and closing any nonconformities issued.

* Bachelor's degree from an accredited University
* 2+ years' experience in a regulated industry
* Strong interpersonal and communication skills.
* Demonstrated in-depth knowledge of Good Manufacturing Practices (GMPs), QA systems principles, concepts, industry practices, and standards.
* Demonstrates excellent verbal, written, and interpersonal communication skills with all levels of staff and both internal and external customers.
* Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
* Demonstrated experience as a change agent in driving complex change, understanding the cultural dynamics of the current state of an organization, creating a strategic practical course, balancing the current reality with the need for rapid adoption of the desired future reality which then generates change with a high degree of transformation

About Strategic IT Staffing
With 20 years of staffing experience in the technical information field, Strategic IT Staffing knows the industry well from the most rewarding jobs available to the hottest career choices to make. In addition, we are owned and operated by industry experts who have worked in the information arena for over two decades. When you choose to work through Strategic IT Staffing, you choose a team approach to employment. We match your career choice and skills with an employer who needs your knowledge and expertise. We make sure you are in control of your career. Strategic IT Staffing is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status


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