Quality Engineer

Quality Engineer1. Requirements:a. BS in Engineering, Life Sciences, technical degree, or quality-related field, with 3-5 years direct experience in Quality, within ISO13485 manufacturing environment, extrusion preferredb. Quality certifications (CQE, CQA), Six Sigma Green Belt, auditor training preferredc. Proficiency in GD&T, applied statistical analysisd. Proficiency in Microsoft Office and Minitabe. Strong understanding of ISO13485 and QMSf. Knowledge of root cause analysis, CAPAg. Experience with auditsh. Proficiency in technical writing and reporting2. Position Skillsa. Organization Strong attention to detail; able to adjust and maintain order and focus across shifting priorities and workflowsb. Critical Thinking Apply risk-based, investigative and data-driven process to effectively reconcile quality outcomes with defined requirements and identify actions neededc. Communication Able to deliver clear and concise technical written and verbal communicationd. Mature work ethic Technically independent, with ability to self-direct with minimal supervision3. Reports to: Quality Manager4. Primary job responsibility: Apply Quality Engineering Body of Knowledge, Six Sigma methodology and statistical analysis to lead and facilitate CAPA and Complaints processes, continuous improvement, and root cause investigation; apply metrology principles and measurement techniques, and advanced data-driven and risk-based skills to improve inspection accuracy, efficiency and productivity within the QC workflow5. Essential functions of positionSubject Matter Expert Metrologya. Interpret/understand design intent from detailed Engineering Drawings and specificationsb. Lead the Engineering Change Control workflow to develop, define and improve measurement methods utilized for the inspection of a broad array of extruded tubes to align with customer print, design intent and defined quality requirementsc. Facilitate the MSA/Gage R&R workflow and perform analysis to reconcile, assess and mitigate measurement error to ensure measurement accuracy, consistency and reliabilityd. Support the workflow and deliverables for the creation, release and training of automated inspection routines utilizing Vision System programmingCAPA and Complaint Processa. Lead, coordinate, and perform the required activities within the CAPA and Complaint workflowsb. Perform and/or facilitate Root Cause Analysis for non-conformitiesc. Initiate, facilitate, and compile CAPA and Complaint/Feedback documentation and reportsd. Manage, maintain, monitor and track CAPA and Complaint/Feedback logs and compliancee. Utilize the CAPA process effectively to address systemic procedural and/or process gaps and improvement opportunities within QMSf. Utilize Minitab software to perform statistical analysis: ANOVA, hypothesis testing, Gage R&R, and process capability as applicable within all workflowsg. Provide input and data-evidenced guidance to internal teams regarding inspection method alignment, capabilities, and correlationCommunication, Reporting and Cross-functional Collaborationa. Demonstrate effective communication across departments; interact and meet as needed with cross-functional members to facilitate compliance and required actions within all applicable workflowsb. Lead Complaint and CAPA meetings; apply soft project management to assign and track required actions within the workflowsc. Present and discuss statistical and quality outcomesd. Analyze and trend data for KPI reporting to inform Assistant QC Manager and Quality Manger of opportunities for improvement and risk managementDocumentation and Compliancea. Ensure compliance with applicable internal QMS, customer and ISO13485 requirementsb. Maintain accurate and complete records in all required documentationc. Follow defined processes and procedures appropriately and effectivelyd. Draft and revise applicable procedures as warrantedGrowth and Developmenta. Lead product and process improvement initiativesb. Receive CQE and/or additional training in Product Risk Management (pFMEA)c. Statistical Process Control (SPC)d. Equipment validations and automated product acceptance activitiese. Lead auditor / Internal Audit process owner6. Is the work described above checked by another individual? ? YES ? NO7. Work Environment: Combinationa. Office Settingb. Dynamic and fast-paced manufacturing floor, prone to interruptionsc. Exposure to noise, high temperatures, moving machinery, and high-voltage equipmentd. Clean room and gowning requirementsConsistent motor skills and other requirements of the position:Persistent: Standing: 10% Sitting: 75% Walking: 15%Consistent lifting of up to 35 lbs. RarelyMinimum lifting of 1 lb. FrequentlyMaximum carrying distance of up to 30 ft. OccasionallyReaching must be able to reach machines and/or materials up to 6 ft. from floor FrequentlyKneeling N/AClimbing stairs OccasionallyRepetitive motion right/left hand/wrist FrequentlyRepetitive motion right/left foot/ankle N/AContinuous arm motions YesMust be able to avoid potentially moving object which could cause injury YesMust be able to grasp and move object consistently and regularly YesVision: intricate nature of work requires vision of 20/20 with or without corrective lenses YesMust be able to use gaging equipment and tools YesMust demonstrate ability to work productively and efficiently with others YesMicrospec offers competitive wages and benefits including:Sign-On BonusComprehensive Health InsuranceMatching 401K plan annually after 1 yearEntry level 2 weeks paid vacation64 Hours personal/sick time (unused time paid out at end of year)Annual discretionary bonusSalary range-$85k - $105k per year based on experience