Sr. Quality Engineer

ClientMedical Device CompanyEmployment TypeContract on W2 (Need US Citizens Or GC Holders Only)No H1B'sLocationSan Diego, CA (can work at either BD location - Brea as on the REQ or San Diego (SD location is Building D, 1000 Pacific Mesa Blvd, San Diego, CA 92128))Duration / Hours9+ Months Contract, 40 hours per weekPositionSr. Quality EngineerDescriptionCan work at either BD location, Brea as on the REQ or San Diego (SD location is Building D, 1000 Pacific Mesa Blvd, San Diego, CA 92128).Must Haves On The ResumeRisk Management KnowledgeDesign controls exposureKnowledge with Engineering change control processesTargeted knowledge with MDRResponsibilitiesSupport modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirementsImplement Corporate and Business level Quality System procedures for the design center locations under supervisionFacilitate internal quality system audits per the procedural requirementsSupport the management of external auditsLead or support the development of content for the management review processUpdate and report on monthly quality metricsProvide inputs on revisions to Corporate and Business level procedures as necessarySupport supplier management efforts for the design centerMaintain outsourcing relationships with internal customers and suppliers by management of quality agreementsScope Of ResponsibilitiesWork is performed without appreciable directionDetermine and pursue course of action necessary to obtain desired resultsEducational RequirementsA minimum of Bachelor's degree in Science or related disciplineCertified ISO 9001/13485 Lead auditor is desirableKnowledge of Design Control, Risk Management and QMS processesMinimum 1-2 years of experience developing and sustaining quality systems of medical devicesKnowledge And SkillsExposed to internal and external audits as an auditor and/or auditeeSome knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.)Good technical writing, communication skills, and managing small quality system projectsDesirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformancesDesign ControlEU MOD/MORChange controlRisk ManagementProcess ValidationIdentification of CTQ'sHandling of deviations and non-conformancesTest method validationsProper Use of Statistics (Sampling Plans)Advise on Regulations and standardsLiaise with Manufacturing PlantsCAPARoot cause investigation and implementation of corrective / preventive actionsRequirementsBachelor's DegreeA minimum of 9 years of relevant experience or a combination of equivalent education and relevant experienceMinimum 2-3 years of experience supporting design assurance for medical devicesExtensive knowledge of applicable regulatory, Corporate and/or Unit requirementsQuality Engineering tools, Statistics, Problem Solving, strong Interpersonal SkillsLeadership and all forms of communicationASQ Certificate(s) desirable (but not required)#J-18808-Ljbffr