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Innova Solutions ยท 2 days ago
Quality Engineer
New York, NY
Full-time
Hybrid
Mid Level
$70K/yr - $80K/yr
3+ years exp
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Responsibilities
Manage the Corrective Action Board functions, including leading the weekly CAB meeting, following up with CAPA leaders on process, extension requests, and various VAPA stages, and ensuring timely completion of CAPAs throughout the company.
Perform solo CAPA management for relevant Quality CAPAs including Failure investigations, verification of effectiveness, implementation, and any needed training as a result of the CAPA activities.
Engage in and support major and minor internal and external audits, enter findings in the QMS's Audit & CAPA modules, and ensure corrective actions are carried out in a timely manner and are in compliance with relevant ISO, FDA, and MDR requirements.
Initiate engineering change orders to correct drawings, specifications, and Quality System Process/Procedures, and manage/reconcile issues with the document control system including the QMS and its related Work Instruction System.
Assess and document reportability decisions for incoming customer complaints and follow through on complaints from assessment to failure analysis to closure.
Initiate and facilitate continuous improvement projects for Quality Systems and support continuous improvement efforts from other departments as needed.
Support the QA team with other work-related duties as requested, directed or assigned by management.
Qualification
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Required
Minimum of a BS in Engineering or related professional field
3+ years of experience in quality engineering
Good communication skills
Great attention to detail
Preferred
Prior experience in a medical device or other highly regulated environment
ASQ Certification (CQE, CQA, CMDA, CSSBB)
Experience with electrical component inspection and assembly
Benefits
Medical & pharmacy coverage
Dental/vision insurance
401(k)
Health saving account (HSA) and Flexible spending account (FSA)
Life Insurance
Pet Insurance
Short term and Long term Disability
Accident & Critical illness coverage
Pre-paid legal & ID theft protection
Sick time, and other types of paid leaves (as required by law)
Employee Assistance Program (EAP)
Company
Innova Solutions
Innova Solutions is an IT company that specializes in data analytics, cloud computing, cyber security, and machine learning.
10,001+ employees
H1B Sponsorship
Innova Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (248)
2022 (74)
2021 (32)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Raj Sardana
Founder, Chairman and CEO
Company data provided by crunchbase
