Quality Engineer III

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Job Title: Quality Engineer III

Schedule: Full-time, with some flexibility in start/end times (EST)

Job Overview

As a Quality Engineer III, you will play a key role in supporting quality initiatives in response to FDA findings. You’ll work onsite with a cross-functional team to develop, implement, and sustain quality engineering practices that meet internal and regulatory standards. This role focuses on quality assurance within a regulated medical device environment and includes both technical and leadership responsibilities.

Key Responsibilities

• Lead or support departmental and cross-functional engineering initiatives related to quality and compliance.
• Serve as a mentor and provide technical guidance to junior engineers and technicians.
• Investigate, recommend, and implement best-in-class quality engineering practices.
• Ensure effective process controls are in place to support development, qualification, and manufacturing.
• Lead or contribute to the implementation of CAPA, process control, and assurance systems.
• Use systematic problem-solving tools to identify, prioritize, and resolve quality issues.
• Maintain compliance with internal procedures and external regulatory standards (FDA, ISO, etc.).
• Support technical documentation efforts, including risk assessments, validations, and protocol development.
• Promote visibility and communication around quality within functional, site, and corporate teams.

Qualifications

• Bachelor’s degree with 5–7 years of experience, or Master’s degree with 3–6 years of experience.
• Prior experience in the medical device industry is required.
• Strong technical writing skills, with proven experience in authoring quality documentation and reports.
• Detail-oriented and analytical thinker with a methodical approach to problem-solving.
• Experience working with quality systems such as CAPA, NCR, validation, and process controls.
• Familiarity with FDA regulatory standards and QSR (21 CFR Part 820).

Preferred Experience

• Hands-on involvement with remediation projects or FDA audit responses.
• Background in any of the following areas:
  Design Assurance, Supplier Quality, Operations Quality, Software Quality, Metrology, or Microbiology/Chemistry (depending on function).
• Comfortable working in a fast-paced, collaborative team with cross-functional responsibilities.

Seniority level

• Seniority level
  
  Mid-Senior level

Employment type

• Employment type
  
  Contract

Job function

• Job function
  
  Design, Quality Assurance, and Engineering
• Industries Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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