Role Description This role is responsible for ensuring the integrity, compliance, and continuous improvement of global quality systems within a regulated environment. The Global Quality Systems Manager maintains oversight of key quality processes, monitors performance metrics, and drives corrective and preventive actions to enhance system effectiveness. This position partners with cross-functional teams worldwide to strengthen compliance, optimize workflows, and support business objectives. The manager provides strategic guidance on audits, regulatory readiness, and quality documentation while ensuring alignment with ISO 13485 standards. Success requires analytical rigor, strong organizational and communication skills, and the ability to influence teams across multiple geographies. The role includes up to 25% travel, both domestic and international, to support audits, inspections, and collaborative projects. - Maintain, monitor, and improve quality system processes, including nonconformance management, logistics complaints, CAPA, internal audits, and planned deviations. - Review and approve quality records, ensuring accuracy, completeness, and regulatory alignment; escalate systemic issues and drive corrective actions. - Analyze quality performance metrics, present insights to leadership, and ensure actionable follow-up during management reviews and business meetings. - Oversee preparation and documentation of Management Review outputs, ensuring decisions and action items are clearly communicated. - Manage the annual internal audit program, including planning, execution, and verification of corrective actions. - Ensure ongoing compliance with ISO 13485 and other applicable regulations, leading readiness activities for external inspections or audits. - Partner with global cross-functional teams to drive compliance and continuous improvement initiatives, enhancing quality system maturity and culture. Qualifications - Bachelor’s Degree in medical device, life science, chemistry, or a related scientific discipline. - Minimum 7 years of experience in regulated quality systems within the medical device industry. - At least 5 years overseeing quality processes for third-party contract manufacturers or logistics operations. - Strong working knowledge of ISO 13485 requirements and quality system principles; ISO 13485 auditor certification preferred. - Demonstrated decision-making, analytical, organizational, and documentation skills. - Effective communication skills across multiple levels and functional areas. - Ability to manage multiple projects simultaneously while maintaining regulatory compliance. - Proficiency in Microsoft Office Suite and other relevant systems and tools. - Willingness to travel up to 25% for US and international engagements. Benefits - Competitive salary range of $120,000–$150,000 annually. - Health, dental, and vision insurance options. - Paid time off and flexible work arrangements. - Retirement savings and profit-sharing programs. - Professional development and training opportunities. - Supportive, collaborative, and inclusive work environment.

• The Senior Automation Engineer provides subject matter expertise in the design, implementation, and lifecycle management of digital systems • Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing • Lead the creation, review, and approval of URS, FRS, DS / DDS, Functional & Control Narratives • Configure, program, and deploy Digital System within the manufacturing environment • Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules • Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements • Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions

• Identify manual, repetitive, and error-prone processes across engineering teams • Design and implement automation to eliminate operational toil • Support the implementation of security and compliance automation (e.g., policy as code, guardrails, automated checks in CI/CD pipelines) to support security initiatives • Build internal services, tools and scripts that improve developer productivity • Create and maintain “golden path” workflows for provisioning, deployments, CI/CD, and environment setup • Design and optimize GitHub Actions pipelines and CI/CD automation, including GitOps workflows (ArgoCD) for Kubernetes • Collaborate with Platform and SRE teams on infrastructure automation initiatives • Work with FinOps to automate cost visibility, reporting, and optimization workflows where relevant • Support teams in adopting standardized automation frameworks • Document solutions clearly to enable self-service adoption • Measure and continuously improve the impact of automation initiatives

• Develops, maintains, and scales automated test coverage across UI, API, and integration layers. • Build and maintain automated tests using: Playwright and Selenium • Develop API and integration tests using: Postman GraphQL tools (GraphiQL) • Validate messaging workflows using: Mailosaur (MFA, OTP, notifications) • Support document validation using: Azure Document Intelligence • Use GitHub Copilot for productivity and test generation • Integrate automated tests into Azure DevOps pipelines • Maintain test data and environment configurations