Senior Software System Engineer - Quality Assurance

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.

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 AbbVie as the Associate Director of Quality Assurance, where you will play a pivotal role in ensuring the highest quality standards in our products. In this leadership position, you will be responsible for developing and implementing quality assurance strategies while collaborating with cross-functional teams to uphold our commitment to excellence.

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.

AbbVie is seeking a Senior Quality Engineer specializing in Combo Product External Quality at the Irvine location. This position plays a key role in maintaining rigorous quality standards across the entire product lifecycle. Role overview The Senior Quality Engineer works closely with teams from various functions to establish and maintain quality assurance processes. The focus is on ensuring products meet strict quality requirements from development through to release. Key responsibilities Collaborate with internal and external partners to implement and monitor quality assurance procedures Support continuous improvement initiatives related to product quality Help ensure compliance with company and regulatory quality standards Impact This role supports AbbVie's commitment to providing reliable healthcare solutions worldwide by upholding high standards in external quality for combination products.

Thank you for your interest in the Manager II, Clinical Quality Assurance position at itcss! We encourage you to explore the details below. If you believe this role aligns with your career aspirations, please discuss with your current manager and HR business partner to assess your qualifications. Should everything align, we invite you to apply, and our Talent Acquisition team will reach out to you for an interview. We look forward to getting to know you!- Your Human Resources TeamAbout the RoleAs the Manager II of Clinical Quality Assurance, reporting to the Director of Clinical Quality Assurance, you will play a pivotal role in overseeing clinical quality support and the management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) supplier qualification program.The ideal candidate will be instrumental in preparing the company for inspections, providing training, and ensuring compliance with current ICH GCP E6 guidance and relevant regulations.Key Responsibilities:Deliver daily clinical quality support and training to ensure compliance with regulatory requirements and internal policies.Manage GCP/GLP/GVP internal and supplier audits, including maintaining the qualification program's audit schedule within the Quality Management System (QMS).Conduct supplier audits and prepare reports as necessary.Compile audit responses and evaluate implementation evidence.Assist in the development of quality systems and processes in the Clinical Quality domain.Review and approve QMS records (deviations, CAPAs, change controls, etc.) for completeness and adherence to SOPs and regulations.Support remediation and corrective action plans, ensuring resolution of quality issues.Assist in reviewing Clinical Quality Management Plans (CQMPs) for trials and vendor performance.Manage clinical training curricula and assist in creating tools to track quality metrics.Support risk assessments and conduct periodic reviews of clinical trial systems (e.g., CTMS, TMF).Collaborate with Quality Management to maintain compliance with various 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.

AbbVie Inc. seeks a Senior Quality Engineer focused on Risk Management for its Irvine location. This position plays a key role in upholding product quality and compliance throughout the development process. Role overview This role centers on applying risk management principles to support the delivery of therapies to patients. The Senior Quality Engineer will work to maintain high standards and ensure that products meet regulatory and company requirements. What you will do Support risk management activities across product lifecycles Contribute to quality assurance processes and compliance efforts Help drive continuous improvement in product quality Requirements Experience with risk management in a quality engineering context Strong understanding of product compliance standards Ability to collaborate with cross-functional teams

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

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.

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.

About the Role The Associate Director of R&D Quality Assurance at Tarsus Pharmaceuticals plays a crucial role in overseeing the quality of early-stage contract drug product manufacturers, contract packagers, contract testing labs, contract raw material manufacturers, and contract warehouses. Reporting directly to the Director of Quality Assurance, this position involves reviewing and approving investigations related to production, deviations, and laboratory out-of-specifications (OOS). You will also handle change controls associated with master manufacturing records and testing methods, as well as validation protocols and reports for drug products, APIs, and label specifications. This role additionally supports vendor management, supplier audits, and the formulation of quality agreements. Key Responsibilities: Lead and manage Quality Assurance activities for early-phase clinical development programs (preclinical through Phase I/II). Develop, implement, and maintain Quality Management Systems (QMS) to support early development initiatives. Ensure compliance with global GxP regulations (GCP, GLP, GMP) alongside Tarsus’ internal policies and industry standards. Provide strategic QA insights to cross-functional teams including Clinical Development, Regulatory Affairs, Analytical Development, Supply Chain, and CMC. Act as the QA representative on development project teams and advise 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 Tarsus’ QMS. Review and approve CMO’s master batch records, analytical documents, and validation protocols. Review executed batch records and determine product disposition per internal policies. Participate in CMO and Tarsus operation meetings. Support two/three-arm blinded studies. Engage in vendor calls. Factors for Success: Bachelor’s Degree with 12+ years of experience in the pharmaceutical industry. At least 7 years of experience in Pharmaceutical Quality Assurance. Proficiency in investigations using root cause analysis, CAPA, and CAPA effectiveness. Exceptional attention to detail. Strong technical skills across various platforms. Comprehensive knowledge of Microsoft Office Systems. Analytical skills to interpret statistical data.

About the Role:The Quality Compliance Manager II plays a vital role in overseeing the Product Quality Complaint program, ensuring that all complaints are managed in strict adherence to Good Manufacturing Practices (GMPs) and the expectations of health authorities. This position will also contribute to the Annual Product Reviews and support various Quality Management System (QMS) areas as needed, such as audits, inspections, change control, document control, and corrective actions.Key Responsibilities:Manage the entire product complaint process from initiation to resolution, including:Initiating Product Complaint InvestigationsCollaborating with Call Center staff for complaint intakeDirectly following up with complainants when necessaryParticipating in weekly product complaint meetingsDrafting response letters for complainantsReviewing and closing product complaint investigationsContributing complaint data to Annual Product ReviewsPreparing monthly metrics and management review presentationsAssisting with regulatory inspections and audits, as requiredAuthoring and revising controlled documentsStay abreast of the regulatory landscape to proactively enhance systems and procedures for effective complaint management.Ensure proper monitoring and escalation of product complaints, including those requiring expedited attention.Foster effective collaboration and alignment within the Quality team and across internal partners.Compile and ensure timely delivery of data for Annual Product Reviews, including:Coordinating with contributing departmentsPreparing necessary product complaint metricsDelivering the final report on scheduleAssist with recalls or field alerts as necessary.Conduct mock recalls and support other Quality Management Systems, including Document Control, Change Control, and CAPA.Perform any additional duties assigned by department management.

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.

Hello, and thank you for your interest in the Quality Compliance Manager II position at itcss! We encourage you to review the details below. If this role aligns with your career aspirations, please discuss with your current manager and HR business partner to see if your qualifications match. If all goes well, we invite you to apply, and our Talent Acquisition team will reach out for an interview to learn more about you.- Your Human Resources TeamAbout the Role:The Quality Compliance Manager II plays a crucial role in supporting the Product Quality Complaint program, ensuring all complaints are addressed in compliance with Good Manufacturing Practices (GMPs) and health authority regulations. This position will also support Annual Product Reviews and assist in various Quality Management System (QMS) areas as needed, such as audits, inspections, change control, document control, and corrective action and preventive action (CAPA).Key Responsibilities:Manage the product complaint program throughout its lifecycle, including:Initiating Product Complaint InvestigationsCollaborating with Call Center staff for complaint intakeFollowing up with complainants as neededParticipating in Weekly Product Complaint MeetingsDrafting response letters to complainantsReviewing and closing Product Complaint investigationsContributing data to Annual Product ReviewsPreparing monthly metrics and management presentationsSupporting regulatory inspections or partner audits as necessaryAuthoring, revising, or approving controlled documentsStay abreast of regulatory changes and proactively adjust systems and procedures to ensure compliance with company policies and regulations.Monitor and escalate product complaints appropriately, including expedited complaints.Foster strong relationships, cooperation, and alignment with internal Quality partners.Compile Annual Product Reviews, ensuring timely data submission from collaborating departments.Assist with product recalls or field alerts as needed.

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 SpaceX as an RTL Design Engineer where you will play a crucial role in the development and innovation of cutting-edge silicon technologies. You will be responsible for designing, verifying, and implementing RTL code to meet performance, power, and area specifications. Collaborate with cross-functional teams to refine design specifications and verify functionality through simulations and testing. This is an exciting opportunity to contribute to groundbreaking projects in the aerospace sector.