Assistant Engineer, Quality

Job Summary

The Assistant Engineer, Quality is responsible for ensuring end-to-end quality across the product lifecycle, including product quality assurance, supplier quality performance, and maintenance of the Quality Management System (QMS). This role collaborates with cross‑functional teams to monitor product performance, manage nonconformities, support CAPA activities, ensure compliance to regulatory requirements, and drive continuous improvements.

Responsibilities

• Perform and support incoming, in‑process, and final inspections to ensure product compliance with specifications and quality requirements.
• Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
• Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
• Support validation activities including IQ / OQ / PQ, test method validation, sampling plans, and Gage R&R.
• Work closely with engineering and production teams to resolve product performance or reliability issues.
• Maintain product quality records, including inspection reports, validation documents, and product release data.
• Support implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93 / 42 EEC, and internal procedures.
• Assist in document control and maintenance of quality records including SOPs, WI, DHR, and others.
• Participate in internal and external audits, including preparation of documentation, execution support, and management of audit findings.
• Support the management review process by collecting NCR, CAPA, audit, complaint, and quality performance data.
• Assist in supplier qualification activities, including documentation review and raising First Article Inspection Reports (FAIR) requests as required.
• Monitor supplier performance, incoming inspection results, and supplier‑related nonconformity trends.
• Participate in supplier NCR and SCAR investigations; help follow up on corrective action implementation and effectiveness.
• Work with suppliers to improve component quality and reduce recurring quality issues.
• Perform any reasonable task assigned by superior, as applicable.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications :

Preferred Qualifications :

Education

Diploma / Degree in Engineering or related technical field.

Physical Requirements / Work Environment

This position works in offices, laboratories, and manufacturing environments. It requires frequent sitting, standing, and walking, and the ability to differentiate colors. The employee must lift up to 50 pounds and use computers and other digital devices daily. Some international travel is required; a valid international travel passport is necessary. Local travel may also be required, so the ability to operate a motor vehicle and maintain a valid driver license is needed. Reasonable accommodations may be made for those with disabilities to perform the essential functions of this job.

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