Quality Engineering Analyst

Abbott; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott in Alameda, CA is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis in a regulated medical device environment. You will perform trending investigations, analyze complaint data, and support root cause investigations while driving continuous improvement.

This on-site role collaborates with Quality, Operations, Manufacturing and R&D to ensure FDA/ISO compliance.

Qualifications

• Bachelor's degree in Biomedical Engineering or related engineering discipline.
• 2–3 years of experience in medical device or pharmaceutical industries.
• Experience in FDA/ISO regulated environments.

Responsibilities

• Perform complaint tracking and trending activities using quality databases and analytical tools.
• Analyze complaint, CAPA, and quality system data to identify trends and risks.
• Support root cause investigations and CAPA activities.
• Create dashboards and reports using Excel, Power BI, JMP, SQL, and Python.
• Collaborate with Quality, Operations, Manufacturing, and R&D teams.
• Document investigative findings and support regulatory compliance requirements.

Skills

Quality data analysis

CAPA investigations

Excel analytics

Power BI

SQL querying

Python basics

Dashboard development

Education

Bachelor's in Biomedical Engineering

Related Engineering Discipline

Tools

JMP

Excel

Power BI

SQL

Python

Job description

Title: Quality Engineering Analyst

Location: Alameda, CA

Duration: 12 Months

100% Onsite

Summary:

Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Experience Required

• 2 to 3 years of experience in a:


• Medical device industry (preferred)


• Pharmaceutical industry


• FDA and/or ISO regulated environment

Required Education

• Bachelor's Degree in:


• Biomedical Engineering, or


• Related Engineering Discipline

Preferred Certifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification preferred

Required Technical Skills

Candidates should possess experience in the following areas:

• Quality data analysis and trending investigations


• Complaint handling and complaint trend analysis


• CAPA support and root cause investigation methodologies


• Quality systems within FDA-regulated environments


• Data analysis and reporting using Excel and related analytics tools


• Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams

Preferred Qualifications

Strong preference for candidates with experience in:

• JMP


• Advanced Microsoft Excel


• SQL querying and data analysis


• Power BI


• Basic to intermediate Python programming


• Quality and complaint management databases


• Dashboard development and data visualization

Key Responsibilities

• Perform complaint tracking and trending activities using quality databases and analytical tools.


• Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.


• Support root cause investigations and CAPA activities.


• Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.


• Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.


• Document investigative findings and support regulatory compliance requirements.


• Assist with continuous improvement initiatives related to complaint handling and quality trending processes.


• Present findings, recommendations, and data-driven insights to stakeholders.


• Experience working in a medical device or other highly regulated environment.


• Strong analytical and problem-solving capabilities.


• Experience analyzing complaint and quality data.


• Exposure to CAPA processes and root cause investigations.


• Ability to communicate technical findings clearly to cross-functional stakeholders.


• Proficiency with data analytics and reporting tools.

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.