Quality Engineer III / Medical device

Job Title: Quality Engineer III / Medical device

Location: Plano, TX - 75024

Key Responsibilities:

Ensure compliance with FDA 21 CFR 820, ISO 13485, and other relevant regulatory requirements and standards.

Lead and support CAPA (Corrective and Preventive Actions), Non-Conformance Reports (NCRs), and Root Cause Analyses.

Conduct internal audits, support external audits (e.g., FDA, ISO, Notified Bodies), and drive audit readiness across departments.

Collaborate with R&D, Manufacturing, Regulatory, and Supply Chain teams to implement quality plans and risk mitigation strategies.

Review and approve engineering change orders (ECOs), design history files (DHFs), and device master records (DMRs).

Participate in design control activities including design reviews, risk assessments (FMEA/DFMEA/PFMEA), and validation/verification testing.

Analyze product and process data to identify trends, implement process improvements, and reduce variation.

Support supplier quality management including supplier audits, quality agreements, and performance monitoring.

Lead or support the creation and maintenance of quality system procedures, work instructions, and training materials.

Drive continuous improvement projects using Lean Six Sigma or other structured methodologies.

Required Qualifications:

Bachelor's degree in Engineering, Life Sciences, or a related technical field.

4+ years of quality engineering experience in the medical device industry.

Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable global regulations.

Experience with CAPA, NCRs, complaint handling, and audit support.

Proficient in quality tools such as FMEA, Root Cause Analysis (RCA), 5 Whys, Fishbone, etc.

Experience with validation/qualification activities (IQ/OQ/PQ).

Familiarity with statistical techniques and data analysis.

Excellent communication, collaboration, and project management skills.