Quality Engineer

Quality Engineer Requirements

• BS in Engineering, Life Sciences, technical degree, or quality-related field, with 3-5 years direct experience in Quality, within ISO
  13485 manufacturing environment, extrusion preferred
• Quality certifications (CQE, CQA), Six Sigma Green Belt, auditor training preferred
• Proficiency in GD&T, applied statistical analysis
• Proficiency in Microsoft Office and Minitab
• Strong understanding of ISO
  13485 and QMS
• Knowledge of root cause analysis, CAPA
• Experience with audits
• Proficiency in technical writing and reporting

• Organization – Strong attention to detail; able to adjust and maintain order and focus across shifting priorities and workflows
• Critical Thinking – Apply risk-based, investigative and data-driven process to effectively reconcile quality outcomes with defined requirements and identify actions needed
• Communication – Able to deliver clear and concise technical written and verbal communication
• Mature work ethic – Technically independent, with ability to self-direct with minimal supervision

Quality Manager

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 workflow

• Interpret/understand design intent from detailed Engineering Drawings and specifications
• 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 requirements
• Facilitate the MSA/Gage R&R workflow and perform analysis to reconcile, assess and mitigate measurement error to ensure measurement accuracy, consistency and reliability
• Support the workflow and deliverables for the creation, release and training of automated inspection routines utilizing Vision System programming

• Lead, coordinate, and perform the required activities within the CAPA and Complaint workflows
• Perform and/or facilitate Root Cause Analysis for non-conformities
• Initiate, facilitate, and compile CAPA and Complaint/Feedback documentation and reports
• Manage, maintain, monitor and track CAPA and Complaint/Feedback logs and compliance
• Utilize the CAPA process effectively to address systemic procedural and/or process gaps and improvement opportunities within QMS
• Utilize Minitab software to perform statistical analysis: ANOVA, hypothesis testing, Gage R&R, and process capability as applicable within all workflows
• Provide input and data-evidenced guidance to internal teams regarding inspection method alignment, capabilities, and correlation

• Demonstrate effective communication across departments; interact and meet as needed with cross-functional members to facilitate compliance and required actions within all applicable workflows
• Lead Complaint and CAPA meetings; apply soft project management to assign and track required actions within the workflows
• Present and discuss statistical and quality outcomes
• Analyze and trend data for KPI reporting to inform Assistant QC Manager and Quality Manager of opportunities for improvement and risk management

• Ensure compliance with applicable internal QMS, customer and ISO
  13485 requirements
• Maintain accurate and complete records in all required documentation
• Follow defined processes and procedures appropriately and effectively
• Draft and revise applicable procedures as warranted

• Lead product and process improvement initiatives
• Receive CQE and/or additional training in Product Risk Management (pFMEA)
• Statistical Process Control (SPC)
• Equipment validations and automated product acceptance activities
• Lead auditor / Internal Audit process owner>

• Office Setting
• Dynamic and fast-paced manufacturing floor,…