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Sr. Design Quality Engineer (Bloomington, IN) (Multiple Openings)
Work Location
Aptitude Solution Inc.
3917 W Sawtelle Dr, Bloomington, IN 47404.
Travel to various unanticipated client locations within the United States for a few days for every three months to check the compliance.
Job Duties
Responsible for remediating risk management files for Class III medical devices to comply with 2019 version of ISO 14971; supporting the development of new templates for risk management file in alignment with ISO 14971:2019; developing efficient timelines for risk remediation activities and providing training to support teams; conducting comprehensive gap analysis and remediating for design controls, risk management file; upgrading in-house inspection equipment which reduced inspection time and, in some cases, generated minimal errors due to poka-yoke setup; providing regulatory responses; collaborating on root cause investigations, CAPA, and health hazard evaluations, offering design and risk insights to address in-house/on-field production defects.
Requirements
Must have master’s in industrial engineering / Systems Engineering / Mechanical Engineering / Production Engineering / Electronics Engineering / Technology / Related + 6 months experience as Industrial Engineer / Design Quality Engineer / Quality Engineer / Product Development Quality Engineer/ Technical Writer /Validation Engineer / Related.
Number of Hours
5 days/week, 40 hours per week, 9.00 AM to 5.00 PM
Salary
$68661.00 Per Year
Contact Details
HR Manager, Job ID:IDE/251
Aptitude Solution Inc.
3917 W Sawtelle Dr, Bloomington, IN 47404.
Contact Number. (737) 296-3984
Contact E-Mail: rabin_jaiswal@aptitudesolution.net
Period of Posting
July 22, 2025 to August 8, 2025
This Notice is being posted as a part of the recruitment process because an application, Form ETA 9089, will be submitted for the permanent full-time position of Sr. Design Quality Engineer. Any Person may provide documentary evidence bearing on this application to the:
Certifying Officer
U.S. Department of Labor,
Employment and Training Administration,
Office of Foreign Labor Certification,
200 Constitution Avenue NW, Room N-5311, Washington, DC 20210