LCM Quality Engineer - Medical Devices

Job Description: LCM Quality Engineer - Medical Devices

Job Summary

The LCM (Life Cycle Management) Quality Engineer will provide quality engineering support for medical device products throughout product development, design changes, technology transfer, manufacturing transfer, and sustaining engineering activities. The role ensures compliance with the Quality Management System (QMS), applicable regulatory requirements, and internal quality standards.

Key Responsibilities

• Provide quality engineering support for new product development (NPD), design changes, product transfers, and sustaining engineering activities.

• Develop and maintain Quality Plans and Product Development Process documentation.

• Review and approve verification and validation (V&V) protocols, reports, and related documentation.

• Support the preparation and review of DFMEA and PFMEA documentation.

• Support equipment and process qualification activities, including IQ, OQ, and PQ.

• Participate in quality audits, risk assessments, and continuous improvement initiatives.

• Lead or support root cause analysis (RCA), nonconformance investigations, deviations, and Corrective and Preventive Actions (CAPA).

• Review and manage engineering change orders and product/process change control documentation.

• Apply statistical methods, process capability analysis, and measurement system assessments to evaluate product and process quality.

• Support post-market quality activities, including complaint investigations and quality issue resolution.

• Develop, review, and maintain SOPs, work instructions, and other quality documentation.

• Collaborate with R&D, Manufacturing, Regulatory Affairs, and other cross-functional teams to ensure product quality and regulatory compliance.

Required Skills and Qualifications

• Experience in Life Cycle Management (LCM) Quality Engineering , preferably within the medical device industry.

• Knowledge of medical device regulations and Quality Management Systems.

• Experience with NPD processes, design controls, and sustaining engineering.

• Understanding of verification and validation, risk management, DFMEA/PFMEA, and process validation.

• Experience with nonconformances, deviations, CAPA, root cause analysis, and change control.

• Familiarity with statistical methods, process capability, and measurement system analysis.

• Strong documentation, analytical, problem-solving, and cross-functional communication skills.

Preferred Experience

• Experience supporting medical device product development, manufacturing transfers, and post-market quality activities.

• Familiarity with regulated quality systems and applicable medical device standards.