quality-management-systems jobs in San Diego

Sr QA Engineer leading complex quality investigations, root cause analysis, CAPAs, and NCMRs at a regulated medical device company (Dexcom). Drives Quality Management System excellence through continuous improvement methodologies (Six Sigma, Lean, process capability analysis), owns validation and qualification strategies for equipment/processes/software, and guides design transfer and commercialization from development to high-volume manufacturing.…See more Requires advanced quality engineering knowledge, hands-on technical aptitude, proficiency with data analysis tools (JMP, Excel), and cross-functional leadership across R&D, Regulatory, Manufacturing, and Engineering teams.

Director of IT seeking an experienced leader to oversee IT governance, compliance, and risk management for a biotech company. Responsibilities include drafting and maintaining IT policies aligned with regulations (GDPR, HIPAA, ISO 27001, FDA 21 CFR Part 11, SOX), leading internal and external audits, conducting risk assessments, developing IT quality management systems, and managing an IT team and budget.…See more The role requires 8+ years of IT experience with 3+ years in leadership, strong technical writing ability, and expertise in cloud platforms, network security, and data privacy.

Staff QA Engineer at Dexcom leading manufacturing quality engineering and design control for high-volume medical device automation. The role requires deep expertise in FDA 21 CFR 820 and ISO 13485 compliance, design transfer strategy, process validation, and CAPA/MRB leadership across global manufacturing sites.…See more You will mentor cross-functional teams, drive systemic quality improvements, and represent the organization during regulatory inspections, with strong emphasis on data-driven decision-making and risk-based design methodologies.

Lead a team of Quality Engineers supporting high-volume manufacturing automation, product introductions, and process validation across multiple programs and sites at a regulated medical-device company. Establish strategic direction for quality engineering, Design Control, Design Transfer, Process Validation, and Manufacturing Quality activities while partnering with Engineering, Operations, and R&D to identify and mitigate risks.…See more Drive continuous improvement through quality metrics, CAPA effectiveness, and nonconformance management, and represent Quality Engineering during audits and regulatory inspections. Manage departmental resources, budgets, and staffing while building and developing high-performing teams.

Lead a Quality Engineering organization responsible for developing, implementing, and measuring quality initiatives across L3Harris Technologies. Direct professionals in Quality Engineering and Supplier Quality Engineering; ensure quality is designed into products from ideation through production; oversee compliance with internal, customer, regulatory, and third-party requirements; and drive root cause analysis and corrective action efforts to prevent recurrence of nonconformances.See more

Principal Systems Architect responsible for defining and maintaining the technical architecture of a complex enterprise automation ecosystem spanning RPA, Machine Learning, and GenAI. Will architect data pipelines integrating diverse enterprise systems (SAP, ERP, QMS, PowerBI, Windchill, Atlassian), provide technical leadership on workflow automation and DevSecOps infrastructure, and ensure end-to-end cybersecurity compliance with DoD standards and CMMC.…See more Role requires 14+ years of progressive IT systems architecture experience, demonstrating systems engineering expertise in complex data integration, AI/ML automation, and secure deployment across engineering, manufacturing, quality, and finance domains.

This Staff QA Engineer role leads the design, development, validation, and deployment of Quality Assurance metric dashboards for manufacturing operations, with expertise in medical device quality management systems (QMS), regulatory compliance (FDA 21 CFR Part 11, ISO 13485), and non-conforming event management. The position coordinates site and corporate management reviews, participates in internal and external audits, and supports cross-functional teams in CAPA, risk management, and validation activities.…See more The engineer applies statistical analysis and dashboard tools (Power BI, Tableau, SQL, BigQuery) to drive quality decisions and operational excellence. Success requires direct experience with QMS, nonconforming materials, auditing, medical device regulations, and the ability to lead diverse functional groups in a fast-paced environment.