Quality Engineer

Quality Engineer - IVDR

Location: Remote

Schedule: Full-time, flexible hours (8:00 AM-5:00 PM based on location)

Pay Rate: Up to $45 an hour

Job Type: 1-year contract

Position Overview

The Quality Engineer will support the updating, consolidation, and migration of legacy product risk management files to ensure compliance with IVDR requirements. This role partners closely with cross-functional stakeholders to assess existing risk documentation, identify gaps, and ensure accurate, compliant risk management records within the eQMS.

Key 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.

Qualifications

Education & Experience

• 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.

Technical & Regulatory Knowledge

• 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.
• Familiarity with FDA 21 CFR Parts 210/211 preferred.
• General understanding of risk management regulations, principles, and application.

Skills & Tools

• Strong critical thinking, problem-solving, communication, coordination, and teamwork skills.
• Proficiency in Microsoft Office and Visio.
• Experience with SAP, EtQ, and/or Veeva is a plus

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