Tucker Parker Smith Group (TPS Group) ยท 4 hours ago
Quality Engineer
United States
Contract
Remote
Entry, Mid Level
$0/hr - $45/hr
2+ years expTucker Parker Smith Group (TPS Group) is seeking a Quality Engineer to support IVDR initiatives by managing risk documentation for legacy products. The role involves facilitating risk management assessments, consolidating hazard analysis files, and ensuring compliance with evolving IVDR requirements and global standards.
Staffing & Recruiting
Hiring Manager
Alexia Armendariz
Responsibilities
Facilitate risk management assessments, including updates to risk management plans and reports
Consolidate and update product system hazard analysis files in accordance with company procedures and applicable standards
Coordinate and lead cross-functional meetings to gather required data and ensure completeness and accuracy of risk profiles
Identify existing hazards, assess new risks, and escalate issues requiring additional input or mitigation to management
Support migration of product risk management files into the eQMS, ensuring accurate metadata and proper linkage to legacy DHF binders
Review legacy risk documentation to identify gaps against IVDR transitional activities, new guidance, and updated global risk management procedures
Support additional IVDR-related technical documentation updates, gap assessments, and eQMS migrations as needed
Operate effectively in a dynamic, fast-changing environment while supporting cross-functional teams with shifting priorities
Demonstrate ownership, accountability, and the ability to work independently with minimal oversight
Qualification
Required
Bachelor's degree (or equivalent) in an engineering or related technical discipline
2+ years of experience in quality engineering, risk management, or a related field (or equivalent combination of education and experience)
Working knowledge of quality engineering principles and risk management methodologies
Understanding of medical device regulations and quality systems, including ISO 14971, ISO 13485, MDSAP, and FDA CFR Part 820 (CFR 210/211 preferred)
General understanding of risk management regulations, principles, and practical application
Strong critical thinking, problem-solving, communication, coordination, and teamwork skills
Proficiency with Microsoft Office and Visio
Preferred
Experience with SAP, EtQ, and/or Veeva is a plus
Company
Tucker Parker Smith Group (TPS Group)
The Tucker Parker Smith Group ( TPS Group), is a professional recruiting and staffing firm.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brian Smith
Co-Founder & Managing Partner
N
Nichole Tonning-Smith
Co-Founder & Chief Operations Officer
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