Quality Engineer

Job Summary:

• We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
• The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.

Roles & Responsibilities:

• Support Medical Device Quality Engineering activities.
• Collaborate with R&D, Regulatory, and cross-functional engineering teams.
• Support Design Controls and Risk Management activities.
• Participate in Verification & Validation (V&V) activities.
• Support Change Control and CAPA processes.
• Ensure compliance with GxP requirements.
• Provide Product Development support.

Education & Experience:

• Bachelor's degree in Engineering or a related field.
• 2+ years of Medical Device Quality Engineering experience.
• Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance.
• Excellent communication and problem-solving skills.