Quality Engineer

Quality Engineering SupportProvides quality engineering support during new business development, new program launches and for existing customer programsEssential Duties and Responsibilities:Support new business developmentProvides support to new business development relating to quality matters as neededDraft preliminary Quality Plan, if appropriateProvides cost and time estimates for anticipated quality department services such as metrology or validation servicesFunctions as a resource for applicable ISO Program and QSR Program requirementsSupport Program Launch and Product Realization as functional department representative assigned to team and Program ManagerReviews new program drawings/information/customer specifications to understand program requirementsDetermines quality and reliability standards and ensures dimensional and cosmetic requirements, as well as customer specifications, are defined and understood.Drafts program Quality Plan (as required) and metrology labor plan to include definition of required fixtures, calibration and metrology requirements and measurement methods needed to meet customer requirements for approvalDrafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR's) and new product inspection techniquesConfirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when requiredPrepares Failure Mode Effects Analysis (FMEA), as neededPrepares Traveler DocumentDevelops required Control/Test methodsEnsures First Article Inspection (FAI) and Capability Studies are scheduled and completedCompletes FAI and capability study analysis for submission to customerAuthors operational qualification (OQ) and performance qualification (PQ) protocols and provides training for protocol participantsOversees the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasksAuthors OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusionEstablishes "golden sample" standards and prepares and submits to customer via customer approval form (CAF) as requiredAttends program team meetings to address quality-related mattersPerforms assigned activities in a timely mannerProvide continuous quality engineering support through program end of life.Completes Certificates of Conformance (CoC) for outgoing products, where requiredCollects and analyzes production line data to monitor yield and defect performanceEnsures golden samples are retained and controlledMaintains Device History Records (DHR) as necessaryPerforms periodic risk assessments, as requiredAssists Purchasing Department with maintaining vendor quality requirementsContinuously monitors production to identify quality-related customer issues and supports corrective action plans when necessaryIssue or authorize CCR's as needed. Manages the return of goods, assignments and close out of RC/CA.Conducts root cause investigation and develops corrective action plans for assigned problem reports (PSRs) and quality issuesManages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfactionSupport QBR's with customer and provides/presents quality-related topicsParticipates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processesOccasional domestic travel requiredHas a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO StandardsOther duties as assignedQualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience:High school diploma with five years related experience, Associate's degree (A. A.) or equivalent from two-year college or technical school with three years related experience, or Bachelor's degree (B.S.) in a technical (STEM or Engineering) field, with zero to one year related experience. Experience in a 21CFR Part 820 or ISO 13485 quality system environment strongly preferred. Experience with Six Sigma or Lean manufacturing techniques preferred.