Quality Engineer

Quality Engineer

Volt is immediately hiring for a Quality Engineer in Pacheco, California 94553. As a Quality Engineer you will:

Responsibilities:

• Provides guidance, expertise, and services to ensure process, data, and product quality.
• Leads and drives process and product improvements and provides specialist quality-related services in the IVDR space associated with R&D, Quality Assurance, Manufacturing Engineering, Production, Procurement and Marketing.
• Develops, implements, and evaluates tools and equipment for quality assurance and for product/process improvement.
• The Quality Engineer ETW role defined here will be responsible for Client integration activities including QMS certification maintenance, integration of client QMS, and Quality oversight of the defined IVDR remediation project.
• The QE will provide bridging support for product quality and the site's regulatory compliance standing, supporting inspection readiness.
• This role will provide hands-on, on-site or hybrid, Quality direction to make visible and as needed escalate issues for broader client team and resource engagement.
• The role will also provide Quality support for potential technical transfer of manufacturing and testing from client site(s).
• The QE will support executing integration and IVDR plan including achieving key milestones while providing quality system bridging, and readiness actions required to sustain compliant product supply through the transition.
• Remediation and implementation of Quality Standards and the client QMS per plan.
• Support Site Inspection Readiness via Gemba walks when on site, promoting visibility of key issues identified during baseline, internal compliance audit through remediation.
• Monitor compliance with Registration File (and appropriate Reg Bodies)
• Confirm Product Release is done within Regulatory Standards and pertinent Registration Files.
• Confirm QC Testing, Methods, and Specifications meet Regulatory Compliance requirements and cGMPs.
• Oversee the development and implementation of relevant Quality Plans.
• Develop metrics to deliver product and process improvement.
• Collaborate with client Global Quality Leadership to support compliance and certification requirements

Qualifications & Preferred

Skills:

• Science or Engineering: BS/MS/PhD or equivalent industry experience.
• Minimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodies
• Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR.
• Operations or Quality Experience in Medical Device Manufacturing
• FDA, and EU regulated work experiences desired
• Fluency with Six Sigma and/or Lean Manufacturing desired
• Problem solver, root cause analysis methodology
• Process oriented mindset; data and continuous improvement orientation
• International working experience and willingness to travel globally

Shift available: 1st

Pay Rate: