Senior Quality Engineer — Medical Device Risk & Validation

BD; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

BD is seeking a Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products. You will contribute to manufacturability, scalability, manufacturing transfer and post-launch sustainability of products.

The role requires deep knowledge of quality engineering, risk assessment, and regulatory requirements, with travel up to 25% and collaboration across design, manufacturing, and regulatory teams.

Qualifications

• BS in Engineering; five years’ experience in engineering or quality engineering in medical devices.
• Pharmaceutical or combination product experience preferred
• Knowledge of ISO 13485, ISO 14971, and 21 CFR 210/211/820
• ASQ Quality Engineering Certification is a plus

Responsibilities

• Lead development of risk assessments and test methods.
• Oversee component qualifications, design validation/verification and process validation.
• Lead product investigations and risk-based decision making.
• Assure manufacturing control plans translating design inputs to production.
• Coordinate activities for product development across a product line.
• Support supplier audits and regulatory submissions.

Skills

Quality engineering

Risk assessment

Statistical methods

Root cause analysis

Cross-functional leadership

Regulatory knowledge

Education

BS in Engineering

Tools

Sampling plans

Test method development

Quality tooling

Job description

BD is seeking a Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products. You will contribute to manufacturability, scalability, manufacturing transfer and post-launch sustainability of products.

The role requires deep knowledge of quality engineering, risk assessment, and regulatory requirements, with travel up to 25% and collaboration across design, manufacturing, and regulatory teams.