Quality Engineer

Position Title: Quality Engineer

Work Location: Pleasanton, CA

Assignment Duration: 12 Months

Work Arrangement: Onsite

This position is responsible for providing quality system support, including quality metrics support, audit readiness, and other duties related to the maintenance and improvement of the quality system.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO 13485, Company policies, operating procedures, processes, and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

0-3 years exp - supports the design, manufacturing, and maintenance of safe, compliant medical devices.

This role assists senior engineers with validation activities, quality documentation, and problem?solving in a highly regulated environment governed by FDA 21 CFR 820, ISO 13485, and ISO 14971.

Key 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.

• 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.

• 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.