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:

•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. Qualified candidates should

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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. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email hr_dept@volt.com or call (866) -898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from VOLT and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. 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