Quality Director Jobs

About The Position

Requirements

• Deep understanding of software requirements and best practices toward: IEC 62304 compliance, Software as a Medical Device (SaMD) and Software in a medical device
• Product IOT environment, Digital Health and Clinical Decision Support Tools
• Agile development in medical devices
• Automated testing methodologies
• FDA General Principles for Software Validation
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• FDA Guidance for Post-market Management of Cybersecurity in Medical Devices
• IS0 14971: Risk Management for Medical Devices
• GxP Validation and GAMP guiance
• FDA Computer Software Assurance (CSA)
• Electronic ALM Systems – Requirements, Risk, Test, Defect and Configuartion Management
• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 820, Quality System Regulation
• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 11, Electronic Records; Electronic Signatures.
• Expertise or strong working knowledge of SDLC GxP Tools – ALM for Software, Configuration Management and Defect Management
• Bachelor’s degree with 15+ years of industry experience
• Degree in a technical discipline
• 9+ years of successful management experience in relevant industry

Responsibilities

• Manages the Software Quality Assurance Consumer Applications & Data Platform Solution Team(s). Defines priorities and delegates responsibilities.
• Leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.
• Promote cross-functional understanding and adherence to quality standards and regulatory requirements.
• Responsible for establishing and reporting on key software development metrics.
• Provides coaching and guidance on defining world class project plans, requirements, design, and test cases.
• Create a lightweight SDLC for Class I/II Exempt Applications / Component based on risk and software classifications as defined in IEC 62304
• Work with R&D to ensure development and test processes comply with the latest regulations and identify potential compliance gaps; work with the departments to discuss how to apply best practices to meet regulations.
• With assistance and buy in from departments, update relevant procedures.
• Lead risk management activities to drive collaborative discussions on appropriate mitigation strategies.
• Ensure the team is prepared for regulatory agency audits
• Provide leadership and expertise in the Design/ Phase Review process to ensure compliance to PDP.
• Coordinates, manages and tracks the team’s efforts, ensuring milestones are met within defined budgets and schedules.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.