Senior Development Quality Engineer – Quality & Process Innovation

abbott; Menlo Park (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health Insurance" HIP PPO

Tuition reimbursement

Career development

Job summary

Abbott in Menlo Park (SH Structural Heart) seeks a Senior Quality Engineer to join the Development Quality team. You will provide Development Quality Engineering support to manufacturing and product development, ensuring the delivery of high-quality products to customers.

The role emphasizes leading quality improvement, designing validation test plans, and implementing risk analyses and CAPA within a regulated environment.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Master's degree preferred.
• Minimum 5 years of related work experience in quality engineering.
• Experience in a regulated quality system environment.

Responsibilities

• Leads Product/Process improvement efforts by capturing quality metric data and performing analysis.
• Develops and executes Test Methods, Validation, Verification and Shelf Life protocols and reports.
• Creates Quality Tools & Training Materials and communicates them to teams.
• Develops product quality plans, quality specifications and risk analyses (FMEAs).
• Responsible for Risk Management activities including creating risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems to reduce process variation and defects.
• Lead efforts to identify root causes and implement corrective and preventative actions (CAPA).
• Work with cross functional teams on continuous improvement initiatives.
• Ensure compliance with applicable regulatory requirements and standards.

Skills

Quality engineering

Risk management

CAPA

Regulatory knowledge

Education

Bachelor's degree in related area

Master's degree preferred

Tools

FMEAs

Process validation

Test methods

Job description

Abbott in Menlo Park (SH Structural Heart) seeks a Senior Quality Engineer to join the Development Quality team. You will provide Development Quality Engineering support to manufacturing and product development, ensuring the delivery of high-quality products to customers.

The role emphasizes leading quality improvement, designing validation test plans, and implementing risk analyses and CAPA within a regulated environment.