Manager II, Clinical Quality Assurance

Rivian and Volkswagen Group Technologies combines expertise from two major automotive companies to develop advanced software for electric vehicles. The partnership focuses on operating systems, zonal controllers, and cloud-based connectivity, tackling the challenges of software-defined vehicles and aiming to advance innovation and sustainability in the industry. Role overview The Senior Software System Engineer - Quality Assurance helps shape and improve the software testing framework across the organization. This position is based in Irvine, California and plays a central part in establishing consistent testing practices, setting clear quality metrics, and developing guidelines grounded in both first principles and industry standards. What you will do Establish and refine software testing frameworks to support high-quality automotive software development. Define and uphold clear quality metrics and guidelines for testing, ensuring alignment with industry standards. Enhance automation tools and processes to improve the scalability and effectiveness of testing infrastructure. Support the organization in measuring and maintaining software quality for next-generation automotive technology.

Join our dynamic team at SGS as a Quality Assurance Engineer in Irvine, California. In this pivotal role, you will be responsible for ensuring the highest quality standards in our inspection and field testing services. You will collaborate with cross-functional teams to develop and implement testing strategies that enhance product integrity and customer satisfaction.

Greetings, and thank you for your interest in the Manager II, Quality Assurance (Commercial) position at Tarsus Pharmaceuticals! If you believe this role aligns with your career aspirations, please engage with your current manager and HR Business Partner to discuss your qualifications. If all aligns, we encourage you to apply, and our Talent Acquisition team will reach out for an interview to learn more about you.- Your Human Resources TeamIn this role, reporting to the Associate Director of Quality Assurance, you will play a pivotal role in managing the review and processing of manufacturing Deviations and Laboratory Out of Specification (OOS) cases, as well as overseeing manufacturing-related Change Controls within Tarsus’ Quality Management System (QMS). Your responsibilities will also include authoring Annual Product Reviews, analyzing and trending analytical data, approving Certificates of Analysis, and conducting thorough reviews of manufacturing batch records and product disposition.Key Responsibilities:Approve Vendor Change ControlsAssess vendor documentation such as Master Batch Records and Master Packaging RecordsReview SpecificationsEvaluate and approve Deviations and OOS casesAnalyze and trend data for quality assuranceWrite Annual Product ReviewsDraft and revise relevant Quality Assurance ProceduresReview new proposed master manufacturing records and related process validation protocolsReview and approve Test Record Review Forms and Certificates of AnalysisOversee the review and approval of executed manufacturing and packaging batch recordsComplete Batch Record Review Forms for batch dispositionFinalize Product Disposition Forms and Certificates of ComplianceEngage in internal operations discussionsParticipate in meetings and discussions with Tarsus' manufacturing partners and testing laboratoriesAttributes for Success:Preferred Bachelor's Degree with over 8 years of experience in the Pharmaceutical IndustryMinimum of 5 years in Pharmaceutical Quality AssuranceMeticulous attention to detailProficient technical abilities across various platformsStrong knowledge of Microsoft Office, including charts and graphsASQ Certification is preferred

As a pivotal member of our Quality Assurance team, the Manager II, Quality Assurance will report directly to the Associate Director of Quality Assurance. This crucial role entails the meticulous review and management of manufacturing deviations and laboratory out-of-specification (OOS) reports, along with the assessment of manufacturing-related change controls in alignment with Tarsus’ Quality Management System (QMS). The Manager II will also take charge of authoring Annual Product Reviews, interpreting and trending analytical data, approving Certificates of Analysis, reviewing manufacturing batch records, and determining product disposition.Key Responsibilities:Evaluate and authorize vendor change controls.Scrutinize vendor documents such as Master Batch Records and Master Packaging Records.Review product specifications for compliance.Assess and approve deviations and OOS reports.Conduct data analysis and trend evaluations.Author Annual Product Reviews to ensure product integrity.Revise and author Quality Assurance Procedures as necessary.Examine new master manufacturing records and process validation protocols.Review and approve test records and Certificates of Analysis.Evaluate executed manufacturing and packaging batch records.Complete batch record review forms for product disposition.Finalize product disposition forms and Certificates of Compliance.Engage in internal operations discussions.Collaborate with Tarsus’ manufacturing partners and testing laboratories.

AbbVie Inc. is hiring a Senior Manager, Clinical Quality Assurance based in Irvine. This position leads quality assurance efforts within clinical development, focusing on compliance with regulatory standards and internal policies. Role overview This role manages the creation and execution of quality assurance strategies for clinical trials. The Senior Manager oversees a team of quality assurance professionals, providing direction as they conduct audits and inspections across clinical programs. Key responsibilities Develop and implement quality assurance strategies for clinical development activities Supervise and mentor a team of quality assurance staff Guide the team in performing audits and inspections to ensure compliance and data integrity Promote adherence to regulatory requirements and internal quality standards Requirements Extensive experience in clinical quality assurance Demonstrated leadership and team management skills Commitment to maintaining high standards in clinical trial execution

Become part of a pioneering team where your contributions extend beyond the stars! At Terran Orbital, your role is not just a position – you are a crucial element in driving our mission ahead. As leaders in satellite manufacturing and aerospace innovation, we break barriers daily to provide transformative solutions that enhance our nation’s defense and commercial initiatives. We are a distinct, rapidly growing, and trusted team committed to the swift and efficient design, construction, launch, and operation of cutting-edge satellites for advanced mission constellations. If you are motivated by purpose, inspired by challenges, and eager to make a significant impact on the universe, you will discover a welcoming environment and limitless opportunities for growth here. Together, let us redefine what is achievable in orbit and beyond!Terran Orbital is seeking a skilled Senior Supplier Quality Engineer to join our vibrant team. Reporting to the Director of Quality, the Senior Supplier Quality Engineer will oversee supplier programs for manufacturing and other operational processes, ensuring adherence to quality programs that meet customer and regulatory standards.

Join Artech Information Systems LLC as a Data Quality Assurance Analyst and play a crucial role in ensuring the integrity and accuracy of our data systems. In this dynamic position, you will work closely with cross-functional teams to develop and implement quality assurance protocols, identify data inconsistencies, and enhance data management processes.Your analytical skills and attention to detail will be vital in monitoring data quality metrics, documenting findings, and driving continuous improvement initiatives.

Join our dynamic team at AbbVie as an Associate Director of Quality Assurance. In this pivotal role, you will oversee quality assurance operations, ensuring that our products meet the highest standards of quality and compliance. You will lead a team in the development and implementation of quality systems and processes, driving continuous improvement initiatives that align with our organizational goals.Your expertise will be crucial in managing audits, regulatory inspections, and ensuring adherence to industry regulations. If you are a proactive leader with a passion for quality and compliance, we encourage you to apply and be a part of our commitment to delivering exceptional healthcare solutions.

About the Role As a pivotal member of the Clinical Quality Assurance team, reporting directly to the Director of Clinical Quality Assurance, the Manager II will spearhead clinical quality support and the management of our comprehensive supplier qualification programs encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP). The ideal candidate will play a crucial role in ensuring inspection readiness across the organization, providing training and guidance to maintain compliance with the latest ICH GCP E6 standards and relevant regulations. Key Responsibilities: Deliver daily clinical quality support and training to uphold adherence to regulatory requirements, company policies, and procedures. Oversee internal and supplier audits related to GCP/GLP/GVP, including the management of the audit schedule within the Quality Management System (QMS). Conduct supplier audits and prepare comprehensive reports as necessary. Compile responses to audits and assess evidence of implementation. Assist in the development and execution of quality systems and processes within the Clinical Quality domain. Review and approve QMS records for completeness and compliance with SOPs and regulations. Support the development of remediation plans and monitor the resolution of quality issues. Contribute to the review of Clinical Quality Management Plans (CQMPs) for clinical trials and vendor performance. Manage and enhance clinical training curricula. Support the creation of tracking tools for reporting quality metrics. Conduct and review Risk Assessments as required. Collaborate closely with Quality Management to ensure compliance with all applicable guidelines and SOPs. Act as a resource for Clinical Development, Operations, and Quality teams.

Join AbbVie, a global biopharmaceutical company, as a Senior Quality Engineer specializing in Combo Product External Quality. In this pivotal role, you will ensure the highest standards of product quality, collaborating with cross-functional teams to maintain compliance and uphold our commitment to patient safety.

Hello! Thank you for your interest in the Associate Director, R&D Quality Assurance position at itcss. We encourage you to review the job details carefully. If this role aligns with your career aspirations, please connect with your current manager and HR Business Partner to discuss your qualifications. If everything checks out, we invite you to apply, and our Talent Acquisition team will reach out for an interview to get to know you better.- Your Human Resources TeamAbout the RoleIn this pivotal role, reporting to the Director of Quality Assurance, you will manage early-stage contract drug product manufacturers, packagers, testing labs, raw material manufacturers, and warehouses from a supplier quality perspective. Your responsibilities will include reviewing and approving investigations related to production, deviations, and laboratory out-of-specifications, as well as overseeing change controls for master manufacturing records, test methods, and validation protocols. You will also support vendor management, audits, and quality agreements.Key Responsibilities:Oversee Quality Assurance activities for early Phase (preclinical through Phase I/II) clinical development programs.Develop and maintain Quality Management Systems (QMS) to support early development activities.Ensure compliance with global GxP regulations (GCP, GLP, GMP) and internal policies.Provide strategic QA input to cross-functional teams including Clinical Development, Regulatory Affairs, Analytical Development, Supply Chain, and CMC.Act as the QA representative on project teams, providing guidance on risk mitigation strategies.Contribute to the writing, review, and approval of SOPs, protocols, reports, and regulatory submissions.Process and approve change controls and deviations within the QMS.Review and approve contract manufacturing organization (CMO) master batch records and validation protocols.Participate in CMO and itcss operational meetings.Support two/three-arm blinded studies and participate in vendor calls.

About Balt Balt is dedicated to transforming the lives of over 150,000 patients by 2026. Our Journey As a trailblazer in the medical device industry for 45 years, Balt has partnered with healthcare professionals and institutions to innovate cutting-edge medical devices. Our products are utilized by medical experts globally, with 13 offices across 11 countries and expanding. Since introducing one of the first neurovascular intervention devices in 1977, Balt has developed the world’s most extensive portfolio of medical devices for stroke care. As the leading global neurovascular platform, we are now venturing into the peripheral vascular sector with our innovative solutions. We take pride in our mission, our passionate team, and the remarkable work we do together to empower physicians in saving lives. Why Join Balt? Be part of a mission-driven team that finds meaning in their work, with a strong sense of pride. Experience a collaborative team environment guided by our core mission, vision, and values. Enjoy recognition, respect, and a multicultural community that contributes to our collective success. We prioritize the well-being of our employees, regardless of location. Ready to become part of our story? We invite you to join us! Opportunity Overview – Senior Quality Engineer The Senior Quality Engineer will play a crucial role in enhancing production quality, facilitating the transfer of neurovascular products to production, and managing supplier quality initiatives. This position requires close collaboration with production teams and suppliers, with moderate support from other engineers and management to achieve objectives. The engineer will be responsible for driving continuous improvements in manufacturing and supplier quality processes through technical and innovative solutions for neurovascular medical devices that save lives.

About Us:TP-Link Systems Inc., headquartered in the United States, stands as a global leader in providing reliable networking devices and innovative smart home products. Consistently recognized as the world's top supplier of Wi-Fi devices, TP-Link is dedicated to enhancing lives through advanced connectivity solutions. With a presence in over 170 countries, we are committed to continuous growth and excellence in service delivery.We believe that technology can transform the world for the better! At TP-Link Systems Inc., our mission is to develop dependable, high-performance products that connect users globally to the marvels of technology.With a focus on professionalism, innovation, excellence, and simplicity, our goal is to empower clients to achieve outstanding global performance while enabling consumers to experience a seamless and effortless lifestyle.Overview:We are on the lookout for an experienced Director of Embedded Software Systems to join our Enterprise Engineering Department and lead our embedded software development team. The ideal candidate will possess a robust technical foundation in embedded systems, demonstrate proven leadership abilities, and have a track record of delivering high-quality embedded software solutions. This strategic role demands a vision to drive innovation, optimize system performance, and ensure flawless integration of embedded software in our product offerings.

Anduril Industries develops advanced technology for defense and national security, supporting the U.S. and allied nations. The company uses modern engineering to build military systems, emphasizing rapid development and real-world deployment. Its Lattice OS platform integrates data from multiple sources to provide real-time, 3D command and control for military operations. Air Defense Team The Air Defense group creates robotic systems designed to detect, track, identify, and neutralize aerial threats, especially unmanned aerial systems (UAS). This team oversees the entire lifecycle of the Anduril Air Defense Family of Systems, from initial development and testing to deployment and maintenance in demanding environments. Collaboration is central, with close work alongside product, engineering, sales, logistics, operations, and mission success teams. Role overview The Senior Software Engineer - Air Defense Systems position is located in Irvine, California. This role tackles complex challenges in networking, autonomy, systems integration, and robotics. Engineering decisions here directly influence how Anduril products operate together to achieve mission goals. The team values engineers who move quickly, scale solutions effectively, and deliver reliable outcomes with a focus on mission priorities. A practical and results-focused mindset is key to thriving in this position.

Field AI is revolutionizing the interaction between robots and the real world. Our mission is to architect risk-aware, dependable, and field-ready AI systems that tackle the most intricate challenges in robotics, thereby unlocking the full potential of embodied intelligence. We transcend conventional data-driven methodologies and pure transformer-based frameworks, embarking on a novel journey with globally deployed solutions that yield tangible results and enhance models through real-world applications.We are currently in search of a talented 3D Computer Vision Engineer to spearhead the development of cutting-edge algorithms for 3D reconstruction and spatial comprehension.In this pivotal role, you will engage with high-fidelity laser scanners and imaging sensors to create and refine pipelines for processing, analyzing, and structuring extensive 3D point cloud datasets. Your primary focus will be on computational geometry, ensuring reconstruction accuracy, and implementing production-grade solutions to derive precise geometric insights from real-world data.This position prioritizes robust mathematical expertise and high-performance software development over direct robot hardware implementation.

Join Twitch as a Senior Android Software Engineer and play an integral role in shaping the future of interactive entertainment. In this position, you will leverage your expertise in Android development to create innovative applications that engage millions of users worldwide. Collaborating with cross-functional teams, you will enhance the Twitch platform, ensuring a seamless user experience for our diverse audience.

Join our dynamic team at Sonsoft Inc. as a Software Development Engineer in Test (SDET) specializing in .NET development. In this role, you will be instrumental in ensuring the quality and efficiency of our software products.As an SDET, you will collaborate closely with development and product teams to design and implement automated testing frameworks and strategies. Your expertise in .NET will allow you to contribute significantly to our testing efforts, delivering high-quality software solutions that meet business requirements.

Join a pioneering team at Terran Orbital, where your contributions extend beyond the atmosphere! As leaders in satellite manufacturing and aerospace innovation, we are committed to breaking new ground daily, creating revolutionary solutions that bolster our nation’s defense and commercial ventures. Our dynamic, rapidly expanding team is dedicated to the swift design, construction, launch, and operation of cutting-edge satellites for advanced mission constellations. If you are motivated by a sense of purpose, invigorated by challenges, and eager to make a lasting impact, you will discover a supportive environment here with limitless growth opportunities. Together, we will redefine the boundaries of what is achievable in orbit and beyond!Terran Orbital is in search of a seasoned Software Architect – Embedded Systems to enhance our innovative team. Reporting directly to the Sr. Director, Platforms & Mission Engineering, the Software Architect – Embedded Systems will spearhead the design and integration of cutting-edge multicore software architectures for advanced aerospace and defense platforms. This position demands extensive expertise in cybersecurity, virtualization, hypervisor frameworks, and embedded multicore SoC architectures, along with a proven track record of architecting secure, high-performance solutions for mission-critical systems. As a technical authority, you will establish technology roadmaps, lead analyses of alternatives, and supervise the incorporation of secure software frameworks into embedded platforms. You will collaborate extensively across avionics, RF communications, navigation, and computing domains to deliver robust, scalable, and secure architectures for next-generation missions.

We are seeking a highly motivated and detail-oriented Quality Control Technician to join our team. In this role, you will be responsible for ensuring the quality and safety of our products through rigorous testing and inspection processes. Your keen eye for detail and dedication to quality will contribute significantly to our commitment to excellence.