Quality Engineer

Quality Engineer ETWThe Quality Engineer ETW role defined here will be responsible for Biocare / client integration activities including Biocare QMS certification maintenance, integration of Biocare into Client's QMS, and Quality oversight of the defined Biocare 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 Biocare to Client site(s).The QE will support executing Biocare integration and IVDR plan including achieving key milestones while providing quality system bridging, and readiness actions required to sustain compliant product supply through the Biocare transition.ResponsibilitiesRemediation and implementation of Quality Standards and the Client QMS per planSupport 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 PlansDevelop metrics to deliver product and process improvement.Collaborate with Client Global Quality Leadership to support compliance and certification requirements.EducationScience or Engineering: BS/MS/PhD or equivalent industry experienceExperienceMinimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodiesStrong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR.Operations or Quality Experience in Medical Device ManufacturingFDA, and EU regulated work experiences desiredFluency with Six Sigma and/or Lean Manufacturing desiredProblem solver, root cause analysis methodologyProcess oriented mindset; data and continuous improvement orientationAble to work well in complex environmentGood communicatorSelf-starting, self-reliant, courage of convictionsInternational working experience and willingness to travel globallyProficient in written and spoken EnglishEssential SkillsAudit Readiness: Responsible for external audit activities, i.e., Health authorities, Notified body, Customers, and partnersQMS: Ensuring controls and quality processes are implemented and executed during Operations.Client and CAPA: Assures proper handling of non-conformities and CAPA to correct and improve quality of material, products, and processes in Client Carpinteria including reworks. Monitor and drive closure of quality records including Client and CAPA, assuring a responsive organizational quality culture.Quality Reporting: Present and provide requested quality data from QA to Quality Management Review and KPIs.Validation: Assure QA oversight towards validation and qualification of equipment, systems, and processes including approval of validation plans, protocols, and reports.Supplier Controls: Assure supplier auditing programs are conducted and followed up on.Support: Provide dedicated responsibility supporting Manufacturing, assuring the right checks and controls are in place to guard product quality and quality compliance.Batch Records: Responsible for the review and release of DHRs.Batch Disposition: Releasing or rejecting product based on release criteria.EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.