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.
Numbers & Facts
Location
Lake Forest, CA
Skills
Change Controlunmatched
Communication Skillsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Engineeringunmatched
GxPunmatched
Healthcareunmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Medical Office Administrationunmatched
Problem Solving Skillsunmatched
Product Developmentunmatched
Product Supportunmatched
Quality Engineeringunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Validation Testingunmatched
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