Quality Engineer I

ICONMA, LLC

Pleasanton, CA

JOB DETAILS
SALARY
$27.25–$30.12 Per Hour
SKILLS
Analysis Skills, Biomedical Engineering, Biotech and Pharmaceutical, Cleanroom, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Collection, Detail Oriented, Document Management, Documentation, External Audit, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Health Plan, Healthcare, ISO (International Organization for Standardization), Identify Issues, Internal Audit, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Office, Problem Solving Skills, Procedure Development, Process Validation, Product Testing, Quality Assurance Methodology, Quality Control, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Research & Development (R&D), Risk, Risk Management, Root Cause Analysis, Software Validation, Technical Drawing, Trend Analysis, Validation Plan
LOCATION
Pleasanton, CA
POSTED
1 day ago
Our Client, a Medical Device and Healthcare company, is looking for a Quality Engineer I for their Pleasanton, CA location.
 
Responsibilities:
  • Support validation activities — Assist in equipment, process, and software validation (including CSV), troubleshoot discrepancies, and help plan validation efforts using risk based approaches.
  • Document quality issues — Prepare, review, and maintain quality control documents, reports, and production records.
  • Participate in CAPA investigations — Support root cause analysis and corrective/preventive actions under supervision.
  • Assist with nonconformance management — Help evaluate product defects, deviations, and material review board (MRB) activities.
  • Perform data analysis — Collect and analyze quality metrics to identify trends and improvement opportunities.
  • Support audits and inspections — Prepare documentation and participate in internal audits and external regulatory inspections.
  • Ensure compliance — Follow established procedures and quality standards in a regulated environment (pharma, biotech, or medical device).
  • Collaborate cross functionally — Work with R&D, manufacturing, and supplier teams to address quality issues and support continuous improvement.
 
Requirements:
  • Bachelor’s degree in Engineering, Biomedical Engineering, Quality Engineering, or related field.
  • Understanding of FDA QSR, ISO 13485, and basic risk management principles.
  • Strong attention to detail, integrity, and accountability in documentation and compliance.
  • Ability to interpret technical drawings, procedures, and test methods.
  • Proficiency with MS Office and basic statistical tools.
  • Preferred Qualifications:
  • Internship or co op experience in medical device, biotech, or regulated manufacturing.
  • Familiarity with validation lifecycle, root cause analysis tools, and CAPA systems.
  • Knowledge of cleanroom or GMP environments.
 
Why Should You Apply?

About the Company

I

ICONMA, LLC