Quality Engineer II - MedTech Risk & Validation

bdx; Tempe (AZ); On-site; USD 80,000 - 110,000; Full time

Job summary

BD in Tempe, AZ is seeking a Quality Engineer with 2+ years in medical device quality engineering. You will lead risk assessments, design/process validation, and support audits and regulatory submissions.

The role emphasizes cross-functional collaboration with product development, manufacturing, and suppliers to build robust quality systems and ensure ISO 13485/14971 compliance. Travel up to 25% may be required.

Qualifications

• BS in Engineering or equivalent required.
• Minimum of two years’ experience in engineering or quality engineering in medical device/pharma or equivalent.
• Knowledge of ISO 13485 and ISO 14971.
• Ability to travel up to 25% for business.
• Proven ability to develop risk management files and implement QMS processes.

Responsibilities

• Lead risk assessments, test methods, and design validation/verification.
• Direct product development activities for a product line and coordinate audits.
• Prepare and present technical updates and risk-based decisions.
• Support regulatory submissions and external supplier audits.
• Develop and implement procedures to comply with corporate and industry standards.
• Collaborate with manufacturing, design, and QA to optimize quality systems.

Skills

Quality engineering

Risk management

Design validation

Process validation

Regulatory compliance

Cross-functional collaboration

Education

BS in Engineering

Job description

BD in Tempe, AZ is seeking a Quality Engineer with 2+ years in medical device quality engineering. You will lead risk assessments, design/process validation, and support audits and regulatory submissions.

The role emphasizes cross-functional collaboration with product development, manufacturing, and suppliers to build robust quality systems and ensure ISO 13485/14971 compliance. Travel up to 25% may be required.