Quality Engineer

Core Responsibilities

• QMS, Documentation & Auditing

• Manuals & Procedures: Lead the development and implementation of the Quality Manual, Standard Operating Procedures (SOPs), and Work Instructions.
• Audit Leadership: Manage the internal audit schedule and serve as the primary point of contact for external registrar audits (e.g., ISO 9001) and customer technical assessments.
• Inspection & Test Plans (ITPs): Author and maintain ITPs for critical manufacturing stages, establishing rigorous stage-gate checkpoints from initial sub-assembly through final system integration.
• Calibration & Traceability: Manage the site-wide calibration program for all Measurement and Test Equipment (M&TE). Ensure full material traceability from raw components to the finished product.

• Technical Quality & Process Control

• Testing Validation: Oversee product validation and Factory Acceptance Testing (FAT) to ensure compliance with performance specifications.
• Special Process & Environment Control: Provide quality oversight for "special processes" (e.g., welding, coating, or specialized sealing). Maintain strict cleanliness and environmental standards (e.g., 5S) to prevent contamination during sensitive assembly phases.
• Continuous Improvement: Lead 8D or 5-Why investigations for internal rework and field failures. Drive permanent corrective actions to improve First Pass Yield (FPY) and reduce scrap rates.
• Risk Management: Utilize tools like PFMEA to identify potential failure modes in the manufacturing process and implement preventative controls.