Quality Engineer

Quality Engineer

Volt is immediately hiring for a Quality Engineer in Pacheco, California

As a Quality Engineer, you will:

• 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 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 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 Global Quality Leadership to support compliance and certification requirements

This is a full-time- contract opportunity.

The Ideal Candidate will have:

• 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

PAY RANGE AND BENEFITS:

Pay Range: $60 - $62.68 per hour

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with applicable laws.

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