Senior Quality Engineer – Medical Devices Sustaining QC

Element Science, Inc.; Redwood City (CA); On-site; USD 104,000 - 132,000; Full time

Benefits offered by this job

Stock Options

Medical, dental, and vision insurance

Life Insurance

401(k) retirement plan

Paid Time Off

Paid Holidays

FSA

HSA

Employee Assistance Program

Job summary

Element Science, Inc. is seeking a Sr. Quality Engineer to support quality, reliability, and continuous improvement of our life‑saving medical device technology across the commercial product lifecycle.

You will lead supplier quality programs, partner with Engineering, Manufacturing, Operations, and Supply Chain, and drive CAPAs, risk management, and verification activities to ensure products meet rigorous regulatory requirements.

Qualifications

• 5+ years in quality or sustaining engineering in medical devices.
• Experience with post-market quality activities, CAPAs, and change control.
• Knowledge of ISO 13485, FDA QSR, ISO 14971, IEC 60601-1.
• Experience applying risk management across product lifecycle.
• Strong problem solving and root cause analysis skills.
• Bachelor’s in Engineering or related; Master’s a plus.
• Ability to collaborate across multiple teams.
• Excellent written and verbal communication skills.

Responsibilities

• Sustainment engineering partner for post-market activities ensuring regulatory compliance.
• Oversee product, component, manufacturing, supplier, and design changes.
• Lead nonconformance, complaints, CAPA investigations and actions.
• Work with Engineering/Operations to implement corrective actions.
• Maintain ISO 14971 Risk Management Files with post-market data.
• Track quality metrics to identify trends and drive improvements.
• Provide quality expertise for electrical/electromechanical issues.

Skills

Quality Engineering

Post-market quality

Root cause analysis

Risk management

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

Element Science, Inc. is seeking a Sr. Quality Engineer to support quality, reliability, and continuous improvement of our life‑saving medical device technology across the commercial product lifecycle.

You will lead supplier quality programs, partner with Engineering, Manufacturing, Operations, and Supply Chain, and drive CAPAs, risk management, and verification activities to ensure products meet rigorous regulatory requirements.