Manager Software Quality

Description

The Company 

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. 

Job Purpose

You will be part of a dynamic organization of engineers, scientists and quality specialists developing a novel intradermal biosensor technology. It is an influential role impacting quality and product development, using knowledge of software quality assurance, design control, risk management, as well as software and firmware design and development. You will establish or improve the software quality assurance processes, standard operation procedures, organizational frameworks, and technical infrastructures. You will ensure that Biolinq’s medical device software products meet quality standards and are complying of FDA and EU regulations and international quality system standards. You will ensure that the GxP software are in validated state. You will build and manage the software quality team.

You will verify and   validate software products and non-product software using extensive knowledge of software testing, design control, and risk management. You will provide input to the software quality assurance processes, standard operation procedures, and technical infrastructures. You will contribute to achieve and maintain compliance with regulatory expectations and international quality system standards.

Duties and Responsibilities

• Update and maintain all Software SOPs, including product, non-product, and cybersecurity. 
• Develop and maintain software verification and validation plans, test plans, test cases, test sets, test reports, traceability matrices, and verification and   validation reports
• Conduct software inspection, testing, verification, and validation of firmware, mobile apps, web apps, cloud services, and APIs
• Work closely with the software development team to identify, track, and correct defects
• Engage in quality activities throughout the life cycle of product development
• Design, implement, and maintain manual and automated test framework and infrastructure
• Enable software developers to deliver quality software through Software Development Life Cycle (SDLC) processes and internal audits
• Ensure design, project, and process control documentation are compliant with US and OUS regulations
• Participate in software design review and software change request review
• Apply risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis) for product design and process design
• Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions
• Provide qualitative and quantitative metrics to improve software product quality
• Prepare, support, and ensure the readiness for internal and external audits and inspections
• Plan and execute non-product GxP software assessment, qualification, and validation

Requirements

 Qualifications

• BS or   MS Degree in Computer Engineering, Computer Science, Electrical Engineering,   or equivalent field
• 5+   years’ experience in software quality assurance in regulated medical device   industry (i.e., 510(k), PMA)
• Solid   knowledge of wireless data transmission protocols, particularly BluetoothTM   Low Energy®
• Proven   record of managing software development design control (21 CFR 820.30, ISO   13485), software verification and validation (FDA’s General Principles of   Software Validations), software development life cycle (IEC 62304), and   regulatory submission documentation
• Extensive   experience with ISO 14971 Medical devices — Application of risk management to   medical devices
• Extensive experience with 21 CFR   Part 11
• Excellent   ability to interface with cross-functional department leaders and work in a   fast-paced, multi-disciplinary environment
• Experience   in Quality Assurance with a focus on software testing, design control of   software development, software verification and validation.
• Knowledge of applied statistics and   experience with statistical software applications
• Experience with design, project,   and process control documentation reviews for compliance
• Experience with reviewing software   design and change control
• Experience with software   configuration manageme