Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address can be reached on # .
We have Contract role Quality Engineer for client at Pleasanton, CA. Please let me know if you or any of your friends would be interested in this position.
Position Details:
Quality Engineer - Pleasanton, CA
Location : Pleasanton, CA 94588
Project Duration : 12 Months of contract
Pay Rate : $34.50 per hour on W2
Job Description:
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 problemsolving 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 riskbased approaches.
- Document quality issues Prepare, review, and maintain quality control documents, reports, and production records.
- Participate in CAPA investigations Support rootcause 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 crossfunctionally Work with R&D, manufacturing, and supplier teams to address quality issues and support continuous improvement.
Required Qualifications:
- 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 coop experience in medical device, biotech, or regulated manufacturing.
- Familiarity with validation lifecycle, rootcause analysis tools, and CAPA systems.
- Knowledge of cleanroom or GMP environments.
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address can be reached on # .
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