Essential Duties and Responsibilities, but are not limited to the following:

Plan and Lead projects

Plan and manage all process validation projects and customers related PPAP, FAI, V&V, DVT projects.
Manages all customer related change request from initiating to implementation with partnership from Engineering and Operations.
Responsible for Quality function activities during the production process including working with Quality Technician, Engineering, and customers on method of inspections, development of inspection sheets and ensure product/ process conformity to customer specifications.
Lead New Product Introduction (NPI) activities including manufacturing readiness, inspection method development, validation, planning, and quality documentation.
Support product transfer activities between manufacturing sites while ensuring process consistency, documentation completeness, validation requirements, and customer expectations are achieved.
Manage customer related change request from initiating to implementation with partnership from Engineering and Operations.

Quality Assurance Responsibilities

Provide technical expertise in the Quality arena to Manufacturing team and Engineering team as needed, including but not limited to method of inspections, gaging selection, validation requirement, regulation requirement and processing of inspection data.
Develop and execute Measurement System Analysis (MSA) activities including Gage R&R, Attribute Agreement Analysis, Bias, Linearity, and Stability studies.
Develop and monitor Statistical Process Control (SPC) methodologies, process capability studies (Cp/Cpk), trend analysis, and data-driven process improvements.
Participate in manufacturing risk assessments including PFMEA, process risk analysis, control plans, and implementation of risk mitigation activities.
Represent Quality function in the board talks, Gemba walks, and communicate issues, findings, solutions to respective team members.
Lead investigations related to Nonconforming Material Reports (NCR), Corrective and Preventive Actions (CAPA), Customer Complaints, and Root Cause Analysis while ensuring timely and effective implementation of corrective actions.
Uilize structured problem-solving methodologies including 8D, 5 Why, Fishbone Diagram, Pareto Analysis, DOE, and statistical analysis to identify root causes and implement sustainable corrective actions.
Develop, review, and maintain the Quality portion of SOPs, Inspection Sheets, Control Plans, and other quality documentation to ensure completeness, accuracy, and compliance.
Measure and Report Quality Metrics at plant level
- Track all Quality and Delivery data
- Create and presenting Monthly Quality Metrics at Plant level.
Provide technical guidance and support to Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
Provide technical support to the inspection process techniques
Ensure that all of the required in process inspections are performed and performed correctly.
Participate in internal audits, customer audits, supplier audits, and regulatory Audits. Support corrective actions resulting from audit findings.
Ensure compliance with customer requirements, ISO 13485, FDA Quality System Regulation (QMSR), and applicable regulatory requirements.
Support supplier quality activities including supplier corrective actions (SCAR), supplier investigations, incoming quality issues, and supplier performance improvement initiatives.
Serve as the Quality representative during customer meetings, technical discussions, audits, qualification activities, and issue resolution.
Lead cross-functional teams to resolve quality issues, implement corrective actions, and support manufacturing excellence.
Analyze manufacturing and quality data to identify trends, prioritize improvement opportunities, and support management decision-making.
Provide technical training and mentoring on quality tools, inspection methods, statistical techniques, and quality system requirements.

Continuous Improvements

Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma methodologies, Kaizen, 5S, statistical analysis, and process optimization techniques.
Provide recommendations to the plant management for improvement projects.
Identify and lead manufacturing improvement opportunities to improve process capability, reduce variation, improve yield, reduce scrap, and enhance operational efficiency.

Special Projects

Develop and manage special projects as assigned by management.

Bachelor degree in Engineering with at least 2 years related experience in engineering

Experience in a metal manufacturing work environment preferred

The Quality Engineer is responsible for ensuring product and process quality throughout the manufacturing lifecycle by applying engineering principles, statistical analysis, and risk-based decision making. This position leads quality engineering activities supporting new product introduction, process validation, manufacturing, customer requirements, and continuous improvement initiatives. The Quality Engineer works cross-functionally with Operations, Engineering, Supply Chain, customers, and suppliers to ensure compliance with customer specifications, regulatory requirements, and the Quality Management System while driving operational excellence.

C-Axis PR, Inc

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Quality Engineer