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The Quality Engineer is responsible for supporting customer quality, manufacturing quality, supplier quality, document control, corrective action, audit activities, and continual improvement of the Quality Management System. This position serves as a key liaison between Advanex, its customers, suppliers, and internal manufacturing teams to ensure quality requirements are understood, implemented, maintained, and improved.

DESCRIPTION OF DUTIES AND RESPONSIBILITIES:

• Support the maintenance, implementation, and continual improvement of the company Quality Management System. 
• Own assigned document control activities, including SOP authoring, review, revision, approval routing, implementation, and training coordination. 
• Ensure quality procedures, work instructions, forms, inspection plans, control plans, and related records remain accurate, and aligned with actual practice. 
• Support compliance with applicable quality system standards, including ISO 13485:2016, ISO 9001, IATF 16949, ISO 14001, and customer-specific requirements. 
• Lead and support internal audits, process audits, product audits, and supplier audits. 
• Prepare audit plans, checklists, reports, findings, and corrective action follow-up. 
• Support customer, registrar, and regulatory audits as required. 
• Serve as a primary quality contact for assigned customers and customer quality issues. 
• Lead responses to customer complaints, corrective action requests, and quality concerns. 
• Support nonconforming material investigations, dispositions, and containment activities. 
• Support manufacturing operations with quality problem solving data analysis, investigations, and process improvement. 
• Participate in new product launches and engineering changes through APQP and related quality planning activities. 
• Prepare, review, and maintain Control Plans, Process Flow Diagrams, PFMEAs, inspection plans, capability studies, Gauge R&R studies, and PPAP or customer-required submissions. 
• Review customer drawings, specifications, and quality requirements to ensure internal understanding and compliance. 
• Identify supplier-related quality issues and support supplier improvement activities. 
• Communicate quality requirements to suppliers and follow up on supplier corrective actions as needed. 
• Collect, review, and analyze quality and production performance data to identify trends, risks, and improvement opportunities. 
• Support continuous improvement activities related to quality, customer satisfaction, supplier performance, manufacturing efficiency, and cost reduction. 
• Provide quality-related training and support to production and inspection personnel. 
• Work closely with Production, Engineering, Sales, Purchasing, Shipping, and Management to ensure quality objectives are met. 
• Report risks, delays, quality concerns, or potential missed objectives to management in a timely manner. 
• Perform other duties as assigned.

• Minimum of 3 to 5 years of Quality Engineering experience in a manufacturing environment.
• Bachelor’s degree in related technical/STEM field required. 
• Experience leading internal audits required.
• Experience supporting or leading supplier audits required.
• Experience with document control, SOP authoring, procedure review, revision control, and training implementation required.
• Experience with customer complaints, root cause analysis, corrective actions, preventive actions, and 8D reporting required.

• Experience with APQP, PPAP, Control Plans, Process Flows, PFMEAs, capability studies, and Gauge R&R preferred.
• Working knowledge of ISO 9001 required.
• Experience with ISO 13485:2016 preferred
• IATF 16949 and ISO 14001 experience preferred.
• CQE, CQA, ISO 13485 Lead Auditor, ISO 9001 Lead Auditor, or similar certification preferred.
• Lean Manufacturing or Six Sigma training preferred.

• Strong understanding of Quality Management System requirements and document control practices.
• Strong technical writing skills.
• Strong root cause analysis and structured problem-solving ability.
• Ability to lead cross-functional teams through containment, investigation, corrective action, and effectiveness verification.
• Strong audit skills, including planning, objective evidence review, reporting, and follow-up.
• Ability to interpret blueprints, technical drawings, specifications, and customer requirements.

• Working knowledge of inspection tools and measurement methods, such as calipers, micrometers, pin gauges, optical comparators, vision systems, and load testers.
• Knowledge of SPC, process capability, Gauge R&R, sampling plans, and basic statistical analysis.
• Strong verbal and written communication skills.
• Ability to work independently, manage multiple priorities, and make sound quality decisions.
• Proficient with Microsoft Excel, Word, PowerPoint, and ERP/QMS systems.
• PLEX experience preferred.

• Must be able to work in a manufacturing environment and interact regularly with production, quality, engineering, and management personnel.
• Occasional travel may be required for customer visits, supplier audits, supplier development, or external quality meetings.