Advantage Technical · 14 hours ago
Quality Engineer
United States
Full-time
Remote
Entry, Mid Level
$45/hr - $45/hr
2+ years expAdvantage Technical is seeking a Quality Engineer to support the updating and migration of legacy product risk management files to ensure compliance with IVDR requirements. The role involves collaborating with cross-functional teams to assess existing risk documentation and ensure accurate risk management records within the eQMS.
Staffing & Recruiting
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Facilitate risk management assessments, including updating risk management plans, reports, and system hazard analyses in accordance with company procedures and applicable standards
Coordinate and lead cross-functional meetings to gather required data, ensure completeness and accuracy of risk profiles, and identify new or emerging risks as needed
Escalate issues to management when additional mitigation strategies or inputs are required
Support migration of product risk management files into the eQMS, ensuring accurate metadata and correct linkage to legacy DHF binders in coordination with DHF migration activities
Review legacy risk documentation to identify gaps relative to IVDR transitional requirements, new guidance documents, and updates to global risk management procedures
Support additional IVDR-related technical documentation updates, gap assessments, and eQMS migrations as required
Operate effectively in a dynamic, evolving environment while supporting cross-functional teams with shifting priorities
Demonstrate ownership, accountability, and the ability to work independently with minimal supervision
Qualification
Required
Bachelor's degree (or equivalent) in an engineering, technical, or related discipline
2–3 years of relevant quality engineering or risk management experience, or an equivalent combination of education and experience
General knowledge of quality engineering and risk management principles
Working understanding of medical device regulations and standards, including ISO 14971, ISO 13485, MDSAP, and FDA 21 CFR Part 820
General understanding of risk management regulations, principles, and application
Strong critical thinking, problem-solving, communication, coordination, and teamwork skills
Proficiency in Microsoft Office and Visio
Preferred
Familiarity with FDA 21 CFR Parts 210/211
Experience with SAP, EtQ, and/or Veeva is a plus
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase