Quality Engineer

The Quality Engineer supports new product development and ongoing product maintenance for medical devices. This role ensures that products meet quality and regulatory standards from concept through launch and lifecycle management. The position requires strong technical, analytical, and problem-solving skills, with a focus on design control, process validation, and continuous improvement.

• Apply quality engineering principles, tools, and methodologies to support product development and sustaining projects.
• Ensure all design control and production activities comply with FDA
  , ISO
  , and corporate quality requirements.
• Serve as the Quality representative on cross-functional product teams.
• Review and approve design and process specifications, test methods, and quality documentation.
• Support or participate in internal and supplier quality audits (may serve as auditor‑in‑training).
• Identify and implement process improvements to enhance product quality and compliance.

• Bachelor’s degree in Engineering
  , Science
  , or a related field.
• Minimum 5 years of relevant experience in quality engineering or a regulated medical device environment (or equivalent education and experience).

• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO standards (13485, 14971, MDSAP, EU MDR/IVDR).
• Experience with quality tools and methods such as:
• Risk management, CAPA, and root cause analysis
• Process validation and software validation
• Statistical methods (SPC, DOE, capability analysis, sampling plans)
• Measurement systems analysis and test method validation
• Process mapping and continuous improvement tools (Pareto, histograms, etc.).
• Familiarity with electronic Quality Systems (e.g., Track Wise or similar) preferred.

• Certification in Quality Engineering (CQE) or related field a plus.
• Demonstrated ability to work collaboratively across functions.