ARC-One Solutions

• Oversees the planning, execution, and monitoring of quality and regulatory activities to ensure organizational compliance • Leads and develops a high‑performing compliance team by setting priorities, managing performance to activity, and supporting professional development • Serves as the quality knowledge expert in all related to a SaMD organization and the primary point of contact for the Agile Release Train (ART) and Compliance Teams • Works collaboratively with the ART and management team members to align quality and compliance activities with business and product goals • Promotes Lean-Agile product development principles integrates them into the Quality Management System using a risk-based approach • Identifies, assesses, and communicates quality and compliance risks, providing actionable recommendations to improve product quality and regulatory readiness • Drives continuous improvement initiatives to maintain adherence to Standard Operating Procedures (SOPs), regulatory requirements, and quality standards • Leads the creation, review, approval, and maintenance of quality documentation • Plans and manages quality management projects that support ongoing compliance and continuous improvement • Establishes, monitors, and reports on post-market quality metrics • Manages the internal audit program, guiding internal auditors and ensuring overall organizational compliance • Facilitates external audits and inspections, including Food and Drug Administration (FDA), client, and other regulatory audits, to ensure successful outcomes • Ensures execution of regulatory operations, including standards maintenance, product labeling, Unique Device Identifier (UDI) updates, and medical device reporting requirements.

• Oversees daily operations of production, non-production and redundant database environments on the cloud and on-premises implementations • Formulates policies, procedures, and standards relating to database management and monitors transaction activity and utilization • Reviews database design and integration of systems and makes recommendations regarding enhancement and/or improvements • Develops, manages and tests back-up and recovery plans ensuring that all procedures are functioning properly • Maintains security and integrity controls over the databases • Contributes to the development of a strategy for use of relational databases technology • Advises organization leaders on database concepts and functional capabilities and recommends system changes to programming staff.

• Designs, builds, tests, deploys, releases, and supports a regulated SaaS-based solution as part of a team • Provides innovative solutions to help resolve customer needs • Strives for continuous improvement and supports continuous integration, continuous development, and deployment pipelines • Identifies, encourages and builds automated processes; advocates for automation, continuous improvements and best practices • Participates in all phases of the solution lifecycle and works closely with a variety of internal, external business, and technology partners • Evaluates system and component releases for impact to business processes • Uses technical skills to code review, verify, and validate the software code developed • Gains knowledge of business processes and recognizes how individuals and technology can effectively support the success of business users • Mentors Full Stack Engineers and Jr. Full Stack Engineers in design, development, and adherence to best practices • Collaborates with teams and ensures high-quality code and best practices are followed in a regulated software environment.

• Facilitating PI Planning • Helps team prepare for PI Planning • Facilitates the team in creating draft PI plans • Ensures the team is coordinating with other teams • Helps create team PI Objectives • Helps to ensure PI Objectives are SMART • Supporting Iteration Execution • Facilitates team events • Collaborates with the Product Owner • Improving Flow • Establishes the team Kanban board • Measures and optimizes flow • Coaches Built-in quality practices • Building High-Performing Teams • Fosters and supports Agile Team attributes • Encourages high-performing team dynamics • Becomes a more effective Scrum Master • Serves as a Lean-Agile Leader • Fosters collaboration on the team • Coaches with powerful questions • Resolves team conflicts • Develops team skillsets working with functional managers • Improving ART Performance • Facilitates cross-team collaboration • Builds trust with stakeholders • Coaches the IP Iteration • Helps the team prepare for the Inspect & Adapt event including guiding people through the problem-solving workshop

• Analyzes business requirements and specifications to design Cloud solutions that optimize value and meet customer objectives • Leads the deployment of infrastructure solutions, ensuring seamless integration with existing systems • Evaluates infrastructure performance on an ongoing basis, identifying areas for improvement and cost reduction • Identifies and resolves infrastructure and application defects, working closely with development teams to track and address issues • Delivers and monitors solutions through scripting automations (ex. Python, UNIX shell, YAML, and JSON) • Provides support for and implements DevOps tools such as GitLab and CI/CD Pipelines • Implements Infrastructure as Code (IaC) principles to build and manage infrastructure in a consistent and repeatable way • Develops and implements best practices for automation development and operation • Stays current on emerging Cloud trends and technologies • Collaborates with customers, developers, and stakeholders to understand business needs and deliver effective automation solutions • Documents solutions and processes, sharing knowledge across teams

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description An Infrastructure Architect plays a crucial role in designing, implementing, and maintaining the Cloud infrastructure of the next generation Blood Establishment (BECS) platform. All team members are considered problem-solvers and actively participate in identifying problems and building solutions that solve the root causes. This is a hands-on position that designs, builds, and deploys high quality capabilities and features. The ideal candidate is comfortable leading Infrastructure as Code (IaC) Cloud initiatives while championing availability, reliability, monitoring, and performance excellence. This role collaborates closely with business leaders, product teams, engineers, and other stakeholders to create value. - Analyzes business requirements and specifications to design Cloud solutions that optimize value and meet customer objectives - Leads the deployment of infrastructure solutions, ensuring seamless integration with existing systems - Evaluates infrastructure performance on an ongoing basis, identifying areas for improvement and cost reduction - Identifies and resolves infrastructure and application defects, working closely with development teams to track and address issues - Delivers and monitors solutions through scripting automations (ex. Python, UNIX shell, YAML, and JSON) - Provides support for and implements DevOps tools such as GitLab and CI/CD Pipelines - Implements Infrastructure as Code (IaC) principles to build and manage infrastructure in a consistent and repeatable way - Develops and implements best practices for automation development and operation - Stays current on emerging Cloud trends and technologies - Collaborates with customers, developers, and stakeholders to understand business needs and deliver effective automation solutions - Documents solutions and processes, sharing knowledge across teams Qualifications - Bachelor's Degree or above in Computer Science or related field - 10+ years of deep technical systems experience designing and supporting production environments - 5+ years of hands-on experience in developing, building, and deploying Cloud solutions - 5+ years of experience with AWS services and solutions - 3+ years working with monitoring solutions (ex. Dynatrace) - Skilled in system administration for Unix (Linux) and Windows environments - Skilled in scripting to automate administrative and security processes - In-depth knowledge and hands-on experience of multiple infrastructure automation tools and technologies including Terraform - Proficiency in containerization technologies such as Rancher, Docker, K8S, and EKS - Experience with CI/CD frameworks and tools, including GitLab and Artifactory - Experience with test automation frameworks is a plus - Strong understanding of software development life cycle (SDLC) and Agile methodologies - Experience working in a SaaS-based product development environment or FDA-regulated medical device environment desired - Cloud and Security certifications is a plus Requirements - Flexible work hours in fun collaborative environment - Working remote requires a reliable internet connection - Must have the ability to travel, as needed for company meetings

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description A Scrum Master is expected to follow Lean-Agile Practitioner expectations including adopting a Lean-Agile mindset, embracing continuous learning, and delivering value as a team and a team-of-teams (Agile Release Train or ART). Members of an agile team and/or ART share the following responsibilities: - Connecting with the customer - Planning the work - Delivering value - Getting feedback - Improving relentlessly The goal of an agile team is to be able to continuously deliver value to the customer in the shortest-sustainable lead time possible with high quality, high team morale, and safety. Responsibilities - Facilitating PI Planning - Helps team prepare for PI Planning - Facilitates the team in creating draft PI plans - Ensures the team is coordinating with other teams - Helps create team PI Objectives - Helps to ensure PI Objectives are SMART - Supporting Iteration Execution - Facilitates team events - Collaborates with the Product Owner - Improving Flow - Establishes the team Kanban board - Measures and optimizes flow - Coaches Built-in quality practices - Building High-Performing Teams - Fosters and supports Agile Team attributes - Encourages high-performing team dynamics - Becomes a more effective Scrum Master - Serves as a Lean-Agile Leader - Fosters collaboration on the team - Coaches with powerful questions - Resolves team conflicts - Develops team skillsets working with functional managers - Improving ART Performance - Facilitates cross-team collaboration - Builds trust with stakeholders - Coaches the IP Iteration - Helps the team prepare for the Inspect & Adapt event including guiding people through the problem-solving workshop Qualifications - Bachelor’s Degree - 3+ years of experience being a Scrum Master or relevant agile experience - SAFe Scrum Master certification or Certified Scrum Master with SAFe Experience - Experience as Scrum Master in a Scaled Agile Framework (SAFe) environment preferred - Experience working in a SaaS-based web application environment preferred - Experience in blood banking a plus Working Conditions - The company maintains EST work hour with limited flexibility to accommodate different time zones - Work in a fun, inclusive, collaborative environment where communication, teamwork, and continuous learning foster a supportive culture - Dedicated quiet workspace to ensure focus and productivity - Remote position with occasional travel, which may be required for in-person team meetings, customer meetings, or company events, with advance notice provided

• Designs, builds, tests, deploys, releases, and supports a regulated SaaS-based solution as part of a team • Provides innovative solutions to help resolve customer needs • Strives for continuous improvement and supports continuous integration, continuous development, and deployment pipelines • Identifies, encourages and builds automated processes; advocates for automation, continuous improvements and best practices • Participates in all phases of the solution lifecycle and works closely with a variety of internal, external business, and technology partners • Evaluates system and component releases for impact to business processes • Uses technical skills to code review, verify, and validate the software code developed • Gains knowledge of business processes and recognizes how individuals and technology can effectively support the success of business users • Collaborates with teams, mentors junior engineers, and ensures high-quality code and best practices are followed in a regulated software environment.