Quality Engineer

This is an ON SITE role at Arlington, VT (No Remote)Job ID-4384

Job DescriptionSummary: Provides 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 requiredMeets or exceeds yearly assigned goalsHas a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO StandardsOther duties as assignedCompetency: To perform the job successfully, an individual should demonstrate the following competencies:Analytical – Collects and researches data; Uses intuition and experience to complement data.Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Responds to requests for service and assistance; Meets commitments.Interpersonal – Listens to others without interrupting; Remains open to others’ ideas and tries new things. Behaves in a respectful and professional manner.Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions.Written Communication – Writes clearly and informatively; Presents numerical data effectively; Able to read and interpret written information.Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.Ethics – Works with integrity and ethically; Upholds organizational values.Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; Manages competing demands; Able to deal with frequent change, delays, or unexpected events.Judgment – Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process.Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently.Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality.Safety and Security – Observes safety and security procedures; Uses equipment and materials responsibly.Qualifications: 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: Bachelor’s degree (B.S.) in a technical (STEM or Engineering) field preferred, plus zero to two years related experience. Minimum education requirements are a H.S. diploma with 1 or more years of related quality experience. Experience in a 21CFR Part 820 or ISO 13485 quality system environment strongly preferred. Experience with Six Sigma or Lean manufacturing techniques preferred.