Be an early applicantLess than 25 applicantsPosted by Agency
Yochana IT Solutions INC · 2 days ago
Design Quality Engineer
North Haven, CT
Full-time
Onsite
Senior Level
7+ years exp
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Hiring Manager
Chiravuri Naga Durga Bharathi
Insider Connection @Yochana IT Solutions INC
Responsibilities
Evaluate product issues to ensure patient, user, and security risks are assessed, and act as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware
Update DFMEA and DHF documents as needed as part of the post-market design change management process
Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management
Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post-market life-cycle phase
Support Complaint trending and Severity trending signal dispositions
Maintain risk management file throughout the product lifecycle, ensuring the latest knowledge on risk is reflected in the risk documentation
Assure compliance to organizational procedures, regulatory requirements, and industry standards, and timely completion of assigned CAPAs and audit findings
Make decisions and propose solutions based on calculated risks identified through data analysis
Assist with protocol and implement process validation procedures in accordance with QSR, FDA, and international guidelines
Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities
Qualification
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Required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Excellent communication and technical writing skills
Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments
Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)
Company
Yochana IT Solutions INC
Yochana, Challenging the Status Quo "Thought" is the meaning of Yochana.
501-1,000 employees
H1B Sponsorship
Yochana IT Solutions INC 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 (2)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Anusha Sharath
Manager of human resources
Mohan Krishna Mannava
Founder and owner
Recent News
Company data provided by crunchbase
