Job Description

Senior Quality Engineer – Manufacturing

A well-established manufacturing organization supporting the medical industry is seeking a Senior Quality Engineer to support quality and process improvement across its production operations.

This role works closely with manufacturing and engineering teams to improve product quality, support new product launches, and ensure compliance with quality management systems in a high-volume manufacturing environment.

The company supports a wide range of manufacturing technologies including metal stamping, forming, CNC machining, wire EDM, and metal injection molding (MIM), allowing products to move quickly from concept and prototyping through full production.

Key Responsibilities

• Provide hands-on quality engineering support on the manufacturing floor
• Analyze production data to identify process improvements and reduce downtime
• Develop and maintain quality documentation including APQP, SOPs, and work instructions
• Perform First Article Inspection Reports (FAIR) and PPAP submissions
• Investigate non-conforming materials and support corrective and preventive actions (CAPA)
• Conduct dimensional inspections using metrology equipment such as calipers, micrometers, and gauge pins
• Perform Gage R&R and measurement system analysis
• Support internal quality audits and quality management system compliance
• Work with engineering teams to support new product launches and process validation

Qualifications

• Bachelor’s degree in Engineering or related technical field
• 10+ years of quality engineering experience in manufacturing
• Experience working with ISO 9001 or ISO 13485 quality systems
• Strong knowledge of Lean Manufacturing, Six Sigma, SPC, and FMEA
• Experience with metrology inspection equipment
• Familiarity with ERP systems and Microsoft Office
• Strong analytical and problem-solving skills

Quality Engineering | Manufacturing Quality | ISO 9001 ISO 13485 | APQP | PPAP | FAIR CAPA| Lean Manufacturing | Six Sigma | SPC | FMEA | Metal Manufacturing | CNC Machining | Metal Injection Molding | Precision Manufacturing | Metrology Inspection