Senior Quality Engineer

EDUCATION REQUIREMENTS & PREVIOUS EXPERIENCE

• Bachelor of Science in Electrical Engineering, Computer Engineering, Computer Science or a related scientific field. Advanced degree is a plus.
• 5+ years of progressive quality engineering experience within the medical device industry or another FDA regulated environment or regulatory industry (e.g., aerospace, automotive).
• Minimum of 2 years of demonstrated experience in a project management or project lead role, managing technical or quality-related projects with cross-functional teams.
• Demonstrated expertise with electrical/electronic hardware design, testing, and manufacturing processes in a regulated context.
• Proven, hands‑on experience in applying 21 CFR 820 (QSR), ISO 13485, ISO 14971:2019, and cGMP principles.
• Strong record of utilizing quality tools for risk management (FMEA), design verification/validation, statistical analysis, CAPA, and supplier quality management.
• Excellent technical writing and communication skills, with the ability to clearly convey complex quality and compliance concepts to engineering and operations teams.
• Proficient in Microsoft Office Suite; experience with statistical software, quality management systems (QMS), and project management tools (e.g., MS Project, Smartsheet) is a plus.
• Proven ability to manage multiple priorities and projects independently in a fast‑paced environment.
• Preferred:
  Experience leading or participating in external supplier audits. ASQ Certified Quality Engineer (CQE) and/or Project Management Professional (PMP) certification is a plus.