Quality Engineer - Manufacturing in White , TN in White House

Job Description Job Description

DO NOT PROVIDE RELOCATION

• 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 .
• Working knowledge of ISO 9001 required.
• Experience with ISO 13485:2016
• IATF 16949 and ISO 14001 experience .
• CQE, CQA, ISO 13485 Lead Auditor, ISO 9001 Lead Auditor, or similar certification .
• Lean Manufacturing or Six Sigma training .

• 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 .

• 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.