> Markdown version of [/jobs/ext/2958422-staff-engineer-i-quality-systems](https://www.wearedevelopers.com/jobs/ext/2958422-staff-engineer-i-quality-systems). 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). --- # Staff Engineer I, Quality Systems - **Company:** Jenavalve Technology, Inc. - **Location:** Irvine, CA, United States - **Experience:** Expert - **Salary:** $129,600.0 - **Contract:** Permanent contract - **Skills:** Business Analytics Applications, Verification and Validation (Software) - **Published:** September 17, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=8848006b2353ceda ## About the Role * Bachelor of Science degree in Biomedical Engineering, or equivalent engineering discipline required. Master of Science degree preferred. * Quality Engineering experience in production and/or R&D support is required. * Minimum of 5+ years of experience in the medical device or pharmaceutical industry is required. * Direct experience in regulated manufacturing environment and knowledge of regulations and standards: 21 CFR Part 820, ISO 13485, ISO 14971 Skills and Abilities Required for This Job: * Must adhere to the company code of conduct and contribute to fostering a professional, collaborative, and respectful team working environment. * Highly self-disciplined and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects. * Must be able to work effectively and collaborate within cross functional teams. * Must be able to effectively articulate quality issues, investigation results, and conclusions, both verbally and in writing, to technical and non-technical personnel. * Strong project management and documentation skills required. * Must be able to take initiative and have the ability to perform hands-on work. * Ability to manage multiple tasks with strong attention to detail. * Strong presentation skills to represent Quality as a function during business meetings * Proven risk management skills. Physical Requirements: * Minimal travel (~10%) may be required for audit support activities. * Must be able to follow cleanroom, including compliance with applicable gowning and PPE requirements, and site safety protocols at all times. ## Description * Collaborate with cross-functional teams such as Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes, eQMS system enhancements and validation activities, and ensure QMS requirements are embedded through product lifecycle. * Promote proactive quality culture and support training on quality system fundamentals and practices across Quality and cross-functional groups. * Lead Quality System activities including CAPAs, Nonconformance Reports (NCRs), Material Review Board (MRB), internal audits, management reviews, and quality metrics trending to drive robust corrective and preventive actions. * Support FDA inspections, Notified Body audits, supplier audits, and internal audits, including investigation and timely closure of audit findings. * Support technology innovation and digital transformation initiatives by evaluating and implementing modern analytical tools, automation, and advance quality monitoring systems. * Lead harmonization of quality KPIs across all sites globally * Support software validation activities including, but not limited to, authoring relevant verification/validation documentation such as user/functional requirements specifications, vendor assessments, risk assessments, testing plans, protocols/scripts, and reports, executing verification/validation testing, and developing procedures related to specific software use. * Support RGA process compliance including receipt, evaluation, investigation, and documentation of returned goods while ensuring appropriate linkage to complaints, traceability requirements, and QMS records are maintained. * Act as SME for all quality system processes improvement initiatives * Provide technical guidance to quality specialists and junior engineers supporting the various quality system elements. ## Related Videos - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Data Analytics with Microsoft Fabric: End-to-End Use Case with Data Agents](https://www.wearedevelopers.com/videos/1547-data-analytics-with-microsoft-fabric-end-to-end-use-case-with-data-agents) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) - [Anomaly Detection - Using unsupervised Machine Learning for detecting anomalies in customer base](https://www.wearedevelopers.com/videos/6-anomaly-detection-using-unsupervised-machine-learning-for-detecting-anomalies-in-customer-base) - [Kettle and Pot or Peas in a Pod? A Debate on Open-Source and Proprietary Software](https://www.wearedevelopers.com/videos/1585-kettle-and-pot-or-peas-in-a-pod-a-debate-on-open-source-and-proprietary-software) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk)