Software Quality Engineering Lead
United States of America
Full Time
1 week ago
$187,000 - $207,000 USD
Visa Sponsor
Key skills
Certified Software Quality Engineer (CSQE)Project Management Professional (PMP)Software Quality EngineeringMedical Device Software ComplianceSoftware Verification and ValidationSoftware Requirements and SpecificationsRisk ManagementQuality Management System (QMS)ISO 13485ISO 14971IEC 6230421 CFR Part 82021 CFR Part 11European Union Medical Device Directive (MDD)Medical Device Regulation (MDR)Internal and External AuditsLeadershipProject Management
About this role
Johnson & Johnson MedTech is a leader in healthcare innovation focused on delivering breakthroughs in health. They are seeking a Software Quality Engineering Lead to manage software projects ensuring compliance with regulatory requirements and quality standards while providing leadership in software verification and validation processes.
Responsibilities:
- Manage Direct Reports and oversees their medical device software projects to ensure compliance to local procedures and regulatory requirements
- Review project/program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports)
- Provides direction and leadership for verification and validation of non-product software, products software, software tools and components
- Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation
- Collaborate with project/program teams to ensure software deliverable comply with company procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance
- Provide Quality representation during software problem resolution
- Participate in technical design reviews and project phase reviews
- Utilize knowledge of risk management to ensure a risk-based approach for QMS processes
- Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc
- Support internal audits and external audits by regulatory agencies, as required
Requirements:
- Bachelor's degree in Computer Science, Engineering or related field
- 8 years of experience in the job offered or in a Software Quality Engineering Lead-related occupation
- Certified Software Quality Engineer (CSQE) certification required
- Project Management Professional (PMP) certification required