> Markdown version of [/jobs/ext/4374306-sr-quality-system-engineer](https://www.wearedevelopers.com/jobs/ext/4374306-sr-quality-system-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr Quality System Engineer - **Company:** BALT MANAGEMENT GROUP LLC - **Location:** Irvine, CA, United States - **Experience:** Expert - **Salary:** $90,000 - $115,000 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Systems Engineering, Computer Literacy, Failure Mode Effects Analysis, Microsoft Office, Microsoft PowerPoint, Data Analytics, Ishikawa - **Published:** October 26, 2026 - **Apply:** https://www.careerbuilder.com/job-details/sr-quality-system-engineer-irvine-ca--fa96fc82-c10a-4e89-a284-0ba9ce98395b ## About the Role Systems Engineering, Quality Engineering, Medical Equipment, Cardiovascular, Cerebral Vascular Accident, Multicultural, Systems Engineering, Quality Engineering, Corrective and Preventative Action (CAPA) Systems, Continuous Improvement, * Bachelor's degreerequired, preferably in engineering or science discipline. * Class IIand III implantable medical device experience with focus on neurovascular devices a plus. * Typical experience required is 5+ years as an Engineer in a related field. * Engineering, or a related field; medical device experience strongly preferred. * Experience working within an FDA-regulated medical device or pharmaceutical environment. * Working knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485, and applicable cGMP requirements. * Experience working with electronic Quality Management Systems (eQMS) and/or CAPA and nonconformance management systems. * Experience managing or supporting CAPA investigations through closure, including corrective action implementation and effectiveness evaluation. * Experience investigating nonconformances, deviations, audit findings, complaints, supplier quality issues, or other quality events. * Experience applying formal root cause analysis and structured problem-solving methodologies. * Experience with risk management and FMEA methodologies, including PFMEA and/or DFMEA. * Experience analyzing quality data and identifying trends or recurring issues. * Experience developing and maintaining quality system documentation, investigation reports, and corrective action records. * Demonstrated ability to coordinate cross-functional activities and manage multiple quality-related projects and priorities. * Experience with statistical analysis or quality improvement methodologies is preferred. Skills * Strong problem-solving and critical-thinking skills with the ability to identify systemic issues and develop effective solutions. * Ability to facilitate cross-functional investigations and drive teams toward timely, sustainable resolutions. * Ability to assess evidence objectively and differentiate between symptoms, contributing factors, and root causes. * Ability to develop practical, risk-based corrective and preventive actions that address the underlying cause of an issue. * Strong analytical skills with the ability to evaluate quality data, recognize trends, and support data-driven decisions. * Strong technical writing skills with the ability to clearly document investigations, conclusions, action plans, and outcomes. * Strong organizational and project coordination skills, including the ability to track multiple activities, deadlines, and stakeholders. * Ability to effectively communicate quality issues and recommendations to both technical and non-technical audiences. * Ability to influence and collaborate with Quality, Operations, Engineering, R&D, Manufacturing, and Supply Chain teams. * Strong attention to detail and commitment to maintaining accurate and compliant quality records. * Ability to prioritize competing activities and work effectively in a fast-paced manufacturing environment. * Ability to work independently while effectively contributing to cross-functional teams. * Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint. Work Environment Working conditions are normal for an office environment. Extended computer usage. Standard PPE gowning requirement for cleanroom activities is required. Moderate lifting Extended periods of walking or standing ## Description This fast-paced position will be responsible for sustaining production quality and the transfer of neurovascular products. You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives., * Coordinate and manage CAPA activities from initiation through closure, ensuring investigations, root cause analyses, corrective actions, preventive actions, and effectiveness checks are completed within established timelines. * Lead cross-functional CAPA investigations involving Quality, Manufacturing, Engineering, R&D, Operations, and Supply Chain. * Analyze quality data, trends, nonconformances, complaints, audit findings, process issues, and other sources of quality information to identify potential systemic issues and CAPA opportunities. * Facilitate structured root cause investigations using tools such as 5-Why, Fishbone/Ishikawa, fault tree analysis, process mapping, and other appropriate problem-solving methodologies. * Develop and document comprehensive root cause analyses and risk-based corrective and preventive action plans. * Track CAPA action items, milestones, owners, and due dates; proactively communicate status and escalate overdue or high-risk activities. * Coordinate implementation of corrective actions, including process changes, procedure updates, training, equipment improvements, supplier actions, and other appropriate controls. * Develop and execute CAPA effectiveness checks to confirm that implemented actions have effectively addressed the identified problem and prevented recurrence. * Manage and support the processing of internal Nonconformance Material Reports (NCMRs), including investigation, root cause analysis, disposition, corrective actions, and process improvements. * Participate in Material Review Board (MRB) activities and support investigation of recurring or significant nonconformances. * Identify trends and recurring issues across NCMRs, CAPAs, process deviations, audit findings, and other quality data sources. * Support supplier quality investigations and corrective actions, including communication with suppliers regarding quality concerns and follow-up on supplier corrective actions. * Provide quality-related support to manufacturing and engineering teams to resolve process and product issues. * Partner with Operations and Engineering to implement sustainable process improvements and reduce recurring quality issues. * Review and update procedures, work instructions, forms, and other controlled documents resulting from CAPA and continuous improvement activities. * Support internal and external audits * Prepare CAPA metrics, status reports, and quality trend analyses for management review. * Support continuous improvement initiatives using data-driven methodologies and appropriate statistical tools. * Work closely with production operators, QC inspectors, engineers, and quality personnel to understand issues at the manufacturing floor level.