▷ Urgent: Staff Quality Assurance Engineer
4 weeks ago
Job Description Key Responsibilities: - Assure compliance with software procedures and guide teams on development life cycle appropriateness - Identify task dependencies and ensure effective development and maintenance efforts - Lead both internal and external audits for software quality systems - Provide training on ASP software quality engineering procedures to staff, contractors, and business partners - Lead compliance and risk management activities for software or system projects - Improve software quality processes based on industry trends and regulatory expectations - Ensure compliant, reliable systems prioritizing patient safety are transferred to users - Manage software change control in alignment with quality procedures and work instructions - Implement systems that address evolving regulations - Represent the Software Quality Engineering function during regulatory inspections - Recommend issue resolutions to senior management for compliance and capability concerns - Ensure Quality System Regulations are followed, including FDA, ISO13485, IEC 62304, ISO 14971, and Sarbanes-Oxley - Maintain documented evidence to validate that systems meet specifications and quality standards - Recommend updates to SOPs related to Computer Systems Validation (CSV) - Provide regulatory consulting, training, and assessments aligned with current requirements and trends - Lead continuous improvement in Software Development Lifecycle (SDLC) management - Convert business needs into validated, compliant solution designs - Act as a technical SME for CSV processes and regulatory audits worldwide - Communicate business-related issues or opportunities to next-level management - Perform other duties as assigned Required Qualifications: - Bachelor's degree in Engineering (Software, Computer Science, or Electrical) with 5+ years of experience - or Graduate degree with 3+ years of experience - Relevant certifications such as ASQ CQE, CQM, or CQA preferred - Experience working in regulated industries (e.g., Medical Devices, Aerospace) - Strong understanding of GxP requirements and applicable standards - Experience with embedded software, ATE, data management, or product connectivity - Proficient in system development methodologies and software metrics - In-depth experience in software quality engineering practices and compliance processes - Knowledge of ISO 13485, 21 CFR Part 820, Part 11, ISO 14971, IEC 62366 - Familiarity with configuration management, change control, testing (V&V), and issue tracking - Understanding of cybersecurity and data integrity requirements - Experience in managing projects and leading cross-functional teams - Risk mitigation and failure investigation experience - Skilled in troubleshooting and root cause analysis - Clear communicator with strong writing and presentation skills - Knowledge of embedded software or cloud SaaS applications - Strong leadership in driving SDLC and validation with cross-functional teams - Ability to manage consultants, vendors, and external partners - Excellent written and verbal communication skills - Proven ability to work independently and collaboratively - Competency in project management and change management practices
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