Quality Engineer

Job Summary:

• 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.

Roles & Responsibilities:

• 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.

Education & Experience:

• Bachelor's degree in Engineering or a related life sciences/technical field.
• 2 4+ years of experience in a Quality Engineer role within the life sciences or medical device industry.
• Proficiency in CAD tools (SolidWorks, 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.