4-6 years experience in Medical Device Quality Engineering or Product Development Quality
Expertise in Design Verification & Validation (DV&V) processes
Strong background in design controls and regulatory compliance
Proficient in risk management, particularly dFMEA
Experience with test method validation and DHR review
Familiarity with New Product Development (NPD) practices
Knowledge of FDA/ISO 13485 regulations is preferred
Responsibilities
Review and support design verification protocols and reports
Evaluate and validate test methods and fixtures
Conduct risk management activities and impact assessments
Review production build protocols and design control documents
Support installation qualification activities for software and equipment
Collaborate with teams on defect tracking and quality improvements
Examine mechanical/electrical design changes and inspection plans
Benefits
Collaborative work environment with cross-functional teams
Opportunities for professional development and skills enhancement
Involvement in impactful medical device product lifecycle
Contribution to quality compliance and customer safety
Engagement with regulatory standards and best practices
Full Job Description
Job Description:
We are Seeking a medical device product development, design verification, and quality engineering support with 4-6 years of experience in Quality Engineer.
The ideal candidate will support design verification activities, risk management, design control processes, and quality compliance throughout the product development lifecycle.
Responsibilities:
Review and support design verification protocols, reports, and summary documentation.
Evaluate test method validations, test fixture qualifications, and regression analysis.
Support risk management activities, including dFMEA reviews and impact assessments.
Review build protocols, DHRs, configuration changes, and design control deliverables.
Support installation qualification (IQ) activities for software and test equipment.
Collaborate with cross-functional teams on defect tracking, test execution, and quality improvements.
Review mechanical/electrical design changes and inspection plans for components and sub-assemblies.
Requirements:
Medical Device Quality Engineering.
Design Verification & Validation (DV&V).
Design Controls.
Risk Management (dFMEA).
Test Method Validation.
DHR Review & Documentation.
New Product Development (NPD).
Regulatory Compliance & Quality Systems.
Preferred Skills:
FDA/ISO 13485 Medical Device Regulations.
Product Development Lifecycle.
Cross-Functional Quality Support.
Experience:
4-6 Years in Medical Device Quality Engineering or Product Development Quality.
