LT
Design Quality Engineer
Accepting applicationsL&T Technology Services · Los Angeles, CA
Full-Time Mid_senior aiateganrfsoc
Posted
6d ago
Category
Test
Experience
Mid_senior
Country
United States
Job Description & Skill Requirement:
•Evaluate product issues to ensure patient, user and security risk are assessed, and acting 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 product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
•Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
•Makes decisions and proposes 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:
•Bachelors degree 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)
Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)
The expected salary range for this position is between $55,500 to $99,500 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.
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•Evaluate product issues to ensure patient, user and security risk are assessed, and acting 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 product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
•Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
•Makes decisions and proposes 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:
•Bachelors degree 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)
Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)
The expected salary range for this position is between $55,500 to $99,500 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.
Show more Show less