Quality Engineer III

Title: Quality Engineer III

Location: Pleasanton, CA

Duration: 14 Months


100% Onsite

Summary

The Quality Engineer III ensures that heart-failure medical devices (e.g., implantable pumps, monitoring systems, cardiac support technologies) comply with Quality System Regulations, support safe and effective performance, and meet regulatory and business requirements. The role partners with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to sustain product quality and drive continuous improvement.


Key Responsibilities

Quality System & Compliance

• Verify adherence to GMP/ISO standards and internal Quality System requirements.
• Support major Quality System investigations, including CAPAs, Health Hazard Evaluations (HHEs), and internal and external audits, including FDA inspections.

Risk Management

• Lead risk analysis activities, including FMEA updates for heart-failure devices.
• Collaborate with R&D/Design Quality to revise verification and validation plans based on risk analysis and performance specifications.

Verification, Validation & Sustaining Engineering

• Support and/or own process validation, product validation, and test method validation activities.
• Conduct technical and statistical investigations to optimize processes and ensure compliance with specifications.
• Measure and improve process capability, process controls, and validation efforts.

Manufacturing & Operations Support

• Work closely with Manufacturing and Engineering to ensure compliance with KPIs such as NCMRs, yield, and cost-reduction projects.
• Monitor manufacturing of assigned heart-failure products, ensuring compliance with DMR and Device History Record requirements.

Nonconformance, Complaints & CAPA

• Lead or support investigations into nonconforming materials, complaints, and root-cause analysis.
• Support disposition of nonconforming materials and ensure corrective actions prevent recurrence.

Documentation & Technical Leadership

• Generate and complete protocols and reports for product, process, and test method validations.
• Review and interpret technical drawings and specifications for heart-failure devices.

Required Qualifications

• Bachelor's degree in Engineering or related technical field.
• 3-5 years of experience in medical device quality engineering, preferably in cardiovascular or heart-failure technologies.
• Proficiency in statistical tools.
• Strong understanding of ISO 13485, FDA 21 CFR 820, 14971, and validation principles.

Preferred Qualifications

• Experience supporting implantable or Class III cardiovascular devices (inferred from Heart Failure division context).
• Experience with design verification/validation, risk management, and process validation.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.

• Published on 10 Jun 2026, 6:38 PM