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.