Quality Engineer

Overview

The Quality Engineer (Life Sciences) will support design control and quality activities for regulated medical device products.

The role involves executing design verification and validation, managing risk and change processes, and maintaining technical documentation in compliance with ISO and FDA regulations, while collaborating with cross-functional teams throughout the product lifecycle.

• Lead DHF/DMR/DMR build activities in adherence to ISO 13485 and FDA 21 CFR Part 820 design control requirements.
• Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting.
• Manage change management processes in compliance with ISO 14971 risk management and internal quality procedures.
• Coordinate project activities across Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Create and maintain technical documentation including Design History File (DHF), risk assessments, and engineering reports.
• Support design reviews and ensure traceability of requirements throughout the product lifecycle.

• Bachelor's degree in Engineering or a related life sciences/technical field.
• 24+ years of experience in a Quality Engineer role within the life sciences or medical device industry.
• Proficiency in CAD tools (Solid Works, PTC Creo), GD&T, tolerance analysis, and fixture design.
• Experience with statistical analysis (95/95, tolerance intervals), Minitab, and data integrity practices.
• Familiarity with materials and processes including titanium alloys, CoCr, stainless steel, UHMWPE, PEEK, additive manufacturing, and coatings.
• Knowledge of ISO 13485, ISO 14971, FDA regulatory pathways (510(k), PMA, MDR), DFMEA/pFMEA, and requirements traceability.