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SQA Services

Quality Engineer (AS9100 Aerospace)

Industry Medical Devices

New York, United StatesPosted 3d ago

Job description

Key Responsibilities:

Quality Management System - Maintain compliance with AS9100 Quality Management System requirements. - Support internal, customer, regulatory, and third-party audits. - Assist in the development, implementation, and continuous improvement of quality procedures, work instructions, and process controls.

Manufacturing Quality Support - Review manufacturing processes for compliance with engineering, customer, and regulatory requirements. - Develop and maintain inspection plans, control plans, and quality standards. - Support First Article Inspections (FAI) in accordance with AS9102 requirements. - Evaluate nonconforming material and participate in Material Review Board (MRB) activities. - Monitor process performance and identify opportunities for defect reduction and process improvement.

Corrective and Preventive Actions - Lead investigations of nonconformances, customer complaints, and internal quality issues. - Utilize root cause analysis methodologies including: - 8D - 5 Why - Fishbone (Ishikawa) - FMEA - Develop, implement, and verify corrective and preventive actions (CAPA). - Track effectiveness of corrective actions and ensure timely closure.

Supplier Quality - Support supplier qualification and performance monitoring activities. - Review supplier corrective actions and verify effectiveness. - Participate in supplier audits and source inspections as required. - Analyze supplier quality data and drive continuous improvement initiatives with suppliers.

Product and Process Validation - Support Process Validation and Process Capability studies. - Conduct Measurement System Analysis (MSA) and Gage R&R studies. - Utilize Statistical Process Control (SPC) techniques to monitor manufacturing performance. - Ensure validation documentation meets customer and regulatory requirements.

Customer Support - Act as quality representative during customer visits and audits. - Review customer quality requirements and ensure deployment throughout the organization. - Support customer investigations and corrective action responses.

Continuous Improvement - Lead Lean Manufacturing and Six Sigma quality improvement projects. - Analyze quality metrics and identify trends. - Drive initiatives that improve product quality, delivery performance, and operational efficiency

Required Qualifications:

Education - Bachelor’s degree in quality, Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline.

Experience - 3-7 years of quality engineering experience in an aerospace, aviation, defense, or highly regulated manufacturing environment. - Experience working within an AS9100-certified organization. - Experience with AS9102 First Article Inspection requirements. - Experience conducting root cause investigations and corrective actions.

Technical Skills - Working knowledge of: - AS9100 - AS9102 - ISO 9001 - FAA regulations (as applicable) - Customer aerospace quality requirements - Proficient with quality tools including: - FMEA - SPC - MSA - Control Plans - Process Capability Studies - APQP/PPAP concepts - Ability to interpret: - Engineering drawings - GD&T (Geometric Dimensioning & Tolerancing) - Specifications and technical standards - Experience with ERP and electronic Quality Management Systems (eQMS). - Strong Microsoft Office skills, including Excel data analysis.

Preferred Qualifications: - ASQ Certified Quality Engineer (CQE) - Lean Six Sigma Green Belt or Black Belt - Aerospace manufacturing experience involving machining, assembly, welding, brazing, and special processes - Internal Auditor certification - Ability to apply AI-based tools and technologies, where appropriate, to support quality management activities, data analysis, problem-solving, and continuous improvement initiatives.

Competencies - Analytical thinking and problem solving - Attention to detail - Risk-based decision making - Effective communication and presentation skills - Project management capability - Team collaboration and leadership - Customer-focused mindset - Continuous improvement orientation

Key Performance Indicators (KPIs) - Internal and external defect rates - Corrective action closure effectiveness - Cost of Poor Quality (COPQ) - Customer complaint reduction - Audit findings and closure performance - First Pass Yield (FPY) - Supplier quality performance - On-time completion of quality initiatives

Working Conditions - Combination of offices, laboratory, and manufacturing floor environments. - Frequent interaction with production personnel, suppliers, customers, and auditors. - Occasional travel for supplier audits, customer visits, and training.