R&D Quality Engineer

Our Client is a Global medical device Manufacturer.

We are looking for an R&D quality engineer to support New Product Development (NPD) activities by ensuring the quality and qualification of supplier-provided components used in medical device products. This role partners closely with suppliers, receiving inspection, and cross-functional engineering teams to establish inspection processes, execute validation activities, and ensure components meet quality requirements. The ideal candidate will have hands-on experience in medical device quality engineering, strong documentation skills, and experience supporting component qualification and inspection activities

• Support New Product Development (NPD) supplier quality activities for medical device components.
• Work closely with suppliers to ensure incoming components meet quality and inspection requirements.
• Establish and improve inspection infrastructure for new products and components.
• Coordinate with the Receiving Inspection team and provide training and guidance to inspectors (approximately 20% of the role).
• Execute Test Method Validation (TMV) activities alongside inspection personnel.
• Prepare TMV protocols, reports, and supporting validation documentation.
• Develop and maintain Part Qualification Plans (PQP) for supplier components.
• Optimize inspection and measurement methods to improve quality and process efficiency.
• Troubleshoot inspection methods and resolve issues related to incoming component inspections.
• Route engineering and quality documentation through Windchill for review and approval.
• Support quality documentation and ensure compliance with medical device quality standards.
• Collaborate with cross-functional teams including R&D, Supplier Quality, Manufacturing, and Receiving Inspection.

Top Skills :

• Troubleshoot inspection test methods
• Handling issues in the receiving inspection area
• Execute GR&R/ TMV
• Documentation of part qualification plan

Requirements:

• Bachelor's degree in Engineering or a related technical discipline.
• 2–4 years of Quality Engineering experience.
• Hands-on experience in the Medical Device industry.
• Experience working with supplier-provided components and incoming inspection processes.
• Experience supporting New Product Development (NPD) projects.
• Strong technical documentation and report writing skills.