Design Quality Assurance Engineer III

About the role

The Design Quality Assurance Engineer III supports medical‑device product development from concept through commercialization. You will lead complaint‑reduction initiatives, manage post‑market projects, and ensure compliance with quality system regulations and corporate standards.

Key responsibilities

• Lead complex engineering problem‑solving using analysis, experimentation, and statistics.
• Apply systematic methodologies such as 5 Whys, Is‑Is Not, and DMAIC to prioritize and resolve quality issues.
• Support design‑control activities including design change analysis, inputs/outputs, test methods, reviews, verification, usability testing, process validation, and labeling.
• Create and maintain safety risk‑management artifacts (Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, DFMEA, Risk Management Plan/Report).
• Collaborate on complaint trending, NCEP/CAPA systems, and post‑market product sustaining activities.
• Prepare and deliver formal presentations on product performance to management and cross‑functional teams.
• Support internal and external regulatory audits and develop test‑method validation protocols.
• Work with suppliers to qualify new components, including statistical sampling plans and inspection procedures.

Required profile

• Strong background in medical‑device design assurance and quality systems.
• Experience leading cross‑functional projects and communicating technical information to diverse audiences.
• Ability to interpret and apply regulatory requirements and corporate SOPs.

Required skills

• DMAIC problem‑solving methodology
• 5 Whys analysis
• Is‑Is Not analysis
• Design Controls knowledge
• Hazard Analysis
• Fault Tree Analysis
• Task and Use Error Analysis
• Risk Management
• DFMEA
• CAPA and NCEP processes
• Test method validation
• Statistical sampling plans