About this role
This role involves supporting validation activities for medical device software, ensuring compliance with industry standards, and maintaining quality management systems in a healthcare environment.
Key Responsibilities
- Support validation activities
- Ensure compliance with standards
- Review software deliverables
- Implement quality improvements
- Collaborate with regulatory teams
Technical Overview
The technical scope includes software validation, risk management, and regulatory compliance within medical device development, utilizing standards like ISO 13485, IEC62304, and FDA regulations.
Ideal Candidate
The ideal candidate is a mid-level quality engineer with experience in medical device software validation, regulatory standards such as ISO 13485 and IEC62304, and risk management processes. They should have strong analytical skills and familiarity with FDA regulations.
Must-Have Skills
Support computerized system validation activitiesIdentify and implement changes to ensure quality management systemApply risk-based approach for QMS processesProvide direction for verification and validation of softwareReview project/software deliverablesEnsure compliance with standards and regulations
Nice-to-Have Skills
Experience with surgical roboticsKnowledge of FDA regulationsExperience in medical device industryQuality management systems experience
Tools & Platforms
ISO standardsRegulatory compliance toolsValidation protocols
Required Skills
Support computerized system validation activitiesIdentify and implement changes to ensure quality management systemApply risk-based approach for QMS processesProvide direction for verification and validation of softwareReview project/software deliverablesEnsure compliance with standards and regulations
Hard Skills
ISO 13485ISO14971IEC6230421 CFR Part 82021 CFR Part 11European Union Medical Device DirectiveMedical device software validationRisk managementVerification and validationSoftware requirementsSpecificationsDesign documentationChange controlSoftware development lifecycle
Soft Skills
CommunicationCollaborationAttention to detailProblem-solvingAnalytical thinking
Certifications
Required
Not specified
Preferred
Not specified
Keywords for Your Resume
software quality engineermedical devicesoftware validationrisk-based approachverification and validationISO 13485ISO14971IEC6230421 CFR Part 82021 CFR Part 11regulatory compliancesoftware requirementsdesign specificationschange controlquality management systemrisk managementquality management
Deal Breakers
Lack of experience with medical device validation, No familiarity with ISO 13485 or IEC62304, Bachelor's degree only (must have Master's)
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