Quality Engineer I

Generis Tek Inc.

Pleasanton, CA

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JOB DETAILS

SALARY

SKILLS

Analysis Skills, Audit Metrics, Biomedical Engineering, Biotech and Pharmaceutical, Cleanroom, Code of Federal Regulations, Continuous Improvement, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Data Analysis, Data Collection, Detail Oriented, Document Management, Documentation, External Audit, FDA (Food and Drug Administration), FDA Requirements, Fortune 500 Customers, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Internal Audit, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Office, Operations Processes, Philosophy, 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, Regulatory Requirements, Research & Development (R&D), Risk, Risk Management, Root Cause Analysis, Software Validation, Systems Administration/Management, Technical Drawing, Trend Analysis, Validation Plan

LOCATION

Pleasanton, CA

POSTED

6 days ago

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address

Nikhil.Jhajharia@generistek.com

can be reached on # (630) 576-1935.
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 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.

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 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.

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address

Nikhil.Jhajharia@generistek.com

can be reached on # (630) 576-1935.

About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.

About the Company

Generis Tek Inc.

With over 15 years of experience servicing Fortune 500 customers across the globe, Generis Tek is consistently regarded as a pioneer in the IT and Professional Staffing and Services Industry. Finding the right talent for the job is a tough task, but it’s one we do especially well.

Generís Tek offers wide scope of services from strategizing to implementing that addresses these unique workforce challenges. Our professionals quickly adapt to clients work culture and become a core part of their team. We hire professionals as well as fresh grads from various disciplines to meet our client’s demands. Our focus is to create and manage a seamless stream of resources for a diverse, global, and effective talent pool. Working closely with our clients has enabled them to achieve their strategic objectives, leverage technological innovation and be cost effective.

We are driven by three core principles in changing Staff Augmentation for the better: cost, quality, and responsiveness.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2015

WEBSITE

http://www.generistek.com

Quality Engineer I

Generis Tek Inc.

Pleasanton, CA

About the Company

Generis Tek Inc.

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