Job Title: Quality Engineer III

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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.