Glooko is hiring a
Senior Design Quality Assurance Engineer in Worldwide

Summary

The job is for a Quality System and Design Assurance Manager responsible for developing and maintaining quality programs, ensuring compliance with FDA and ISO regulations, leading risk management activities, managing change control process, creating Quality and Risk Management Plans, participating in the CAPA process, supporting audits, and preparing documentation required by the FDA.

Requirements

• BS or MS degree in Software Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, Regulatory Affairs or another scientific discipline
• Minimum 6-8 years Quality System and Design Assurance experience in the FDA-regulated medical device industry with specific experience working directly with medical device software development teams
• Direct experience with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62034, IEC 82304, and FDA Cybersecurity expectations
• Strong understanding and responsibility for compliance to Design Control Requirements
• In-depth knowledge of Medical Device Risk Management practices according to ISO 14971 including application of Risk Management to all the stages of software development including dFMEA/sFMEA
• Knowledgeable of AAMI Technical Information Reports including: TIR80002-1 – Guidance on the application of ISO14971 to Medical Device Software, TIR45 - Using Agile in Medical Device Software Development and TIR36 - Validation Of Software For Regulated Processes
• In-dept experience in all general FDA and ISO 13485 Quality System processes including: Management Review, Document Control, Training, CAPA, Audits, Complaints, Supplier Management, SOPs, etc
• Ability to lead and manage various Regulatory activities and meetings including CAPA, risk analysis, documentation and audit meetings
• Detail oriented and well organized with excellent skills in written and verbal communications and analytical and strategic thinking
• Ability to work independently and to collaborate effectively on teams

Responsibilities

• Develop, establish, and maintain quality and compliance programs
• Support and assure FDA and ISO 13485 Design Controls requirements on the development processes for Glooko products on cross-functional teams
• Ensure compliance to the elements of Design Controls including Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, and Design History File
• Lead the medical device risk management activities, include FDA cybersecurity requirements, across the global organization
• Facilitate the risk management and dFMEA/sFMEA processes among stakeholders in Engineering, Verification, Clinical, Product and Regulatory
• Lead risk evaluation for pre-market and post-market issues for product safety, including completion of the risk documentation and the risk management file
• Identify potential quality issues in products and processes and deliver guidance on developing effective remediation for addressing them
• Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures
• Collaborate and guide with cross-functional team members and stakeholders to ensure implementation of Design Controls and Quality Systems
• Manage the change control process by monitoring all types of changes that can influence product reliability and quality
• Create Quality and Risk Management Plans for product development projects and manage the plans throughout the development process
• Participate in the CAPA process and work with CAPA owners to address and close CAPAs in a timely manner
• Support Externals Audits from FDA, ISO 13485 and Partners including documentation and follow-up on the action items for audit issues
• Support Internal Audits to document and follow-up on audit issues and assist teams with resolution of the issues

Preferred Qualifications

Experience working on diabetes-related product desired