Senior Design Quality Assurance Engineer

This position is responsible for developing, establishing, and maintaining quality and compliance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards, agency regulations, Glooko’s Quality Policy, Quality Objectives, and Quality Manual. The role involves supporting and assuring FDA and ISO 13485 Design Controls requirements, leading medical device risk management activities, identifying potential quality issues, managing the change control process, participating in audits, and preparing documentation required by the FDA. The ideal candidate should have a BS or MS degree in a relevant field, minimum 6-8 years of experience in Quality System and Design Assurance in the FDA-regulated medical device industry, and strong knowledge of FDA regulations and ISO standards.

• Develop, establish, and maintain quality and compliance programs, policies, processes, procedures, and controls
• Ensure that performance and quality of products conform to established standards, agency regulations, Glooko’s Quality Policy, Quality Objectives, and Quality Manual
• 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, including 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 External 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
• Prepare documentation required by the FDA and assist in maintaining the Glooko Quality System

• 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.
• A lengthy track record in effective application of Design Control best practices to medical device software development teams
• 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-depth experience in all general FDA and ISO 13485 Quality Systems

• Competitive salary and benefits package
• Opportunity to work with cross-functional teams
• Compliance with FDA and ISO 13485 Design Controls requirements
• Lead medical device risk management activities
• Collaborate with stakeholders in Engineering, Verification, Clinical, Product, and Regulatory
• Identify and address potential quality issues in products and processes
• Exercise independent judgment in evaluating processes and systems against regulatory requirements
• Manage change control process to ensure product reliability and quality
• Create Quality and Risk Management Plans for product development projects
• Support Externals Audits from FDA, ISO 13485, and Partners
• Support Internal Audits and assist with issue resolution
• Prepare documentation required by the FDA and maintain the Glooko Quality System
• Opportunity to work in the field of diabetes-related product development
• Joining a company that is a leading player in clinical research for diabetes and other cardiometabolic conditions