2+ years of Medical Device Quality Engineering experience
Strong knowledge of Design Controls and Risk Management
Familiarity with ISO 13485 and ISO 14971 standards
Excellent communication and problem-solving skills
Responsibilities
Support Medical Device Quality Engineering activities
Collaborate with R&D, Regulatory, and engineering teams
Assist in Design Controls and Risk Management
Engage in Verification & Validation (V&V) activities
Facilitate Change Control and CAPA processes
Ensure GxP compliance
Provide support for Product Development
Benefits
Opportunity to work on innovative healthcare products
Collaborative work environment with cross-functional teams
Exposure to diverse aspects of Medical Device development
Professional development opportunities
Contribution to impactful healthcare solutions
Full Job Description
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.
