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Generis Tek Inc • Pleasanton, California, United States
Role & seniority: Sr. Development Quality Engineer (Contract)
Location & work type: Pleasanton, CA; 6+ months contract; $60/hour on W-2
Stack / tools: Medical device quality systems; DOORS (requirements management); JIRA (issue tracking); familiarity with risk management methods and statistics concepts
Lead/support on-time completion of design control deliverables
Establish objective product requirements and lead Design Verification & Validation planning and execution
Lead risk management activities from concept through commercialization; support test method development/validation and quality system improvements
Bachelor’s degree in Engineering or technical field
≥5 years in R&D, process/manufacturing engineering, and/or quality, with ≥2 years in product development
Experience in medical devices and related regulations/standards; test method development/validation; risk assessments (FMEA)
Advanced engineering/technical degree
Experience with active implantable medical devices
Knowledge of DOORS and JIRA; applied statistics for V&V
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address Deb.Chatterjee@generistek.com can be reached on # (630) 576-1905.
We have Contract role Sr. Development Quality Engineer for our client at Pleasanton, CA. Please let me know if you or any of your friends would be interested in this position.
Location: Pleasanton, CA 94588
Project Duration: 6+ Months Contract
Pay rate: $60/hour on W2
The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.
RESPONSIBILITIES
Lead and/or support on-time completion of Design Control deliverables
Support the establishment of objective, measurable, and verifiable product requirements
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
Lead Risk Management activities from product concept through commercialization
Support test method development and lead test method validation activities
Support manufacturing process development & qualification for new product and design changes
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
Support biocompatibility and sterilization qualifications
Support audits and quality system improvement activities
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
Bachelor’s degree in Engineering or Technical Field.
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
Experience in medical devices and associated regulations/standards.
Experience in test method development and validation
Experience in preparing risk assessments, FMEA and other risk documents.
Advanced Degree in Engineering/Technical Field
Experience in active implantable medical devices.
Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
Working knowledge of statistics and its application to verification and validation?
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address Deb.Chatterjee@generistek.com can be reached on # (630) 576-1905.