Senior Quality Systems Software Architect

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⛰️ Colorado, North Carolina – Remote

⛰️ Colorado – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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JSR Micro, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

Semiconductor • Manufacturing • Technology

JSR Micro, Inc. is a leading supplier of high-performance semiconductor lithography materials. With over 30 years of excellence in manufacturing and innovation, JSR Micro focuses on developing advanced electronic materials, particularly for the semiconductor industry. The company recently expanded its capabilities by acquiring Yamanaka Hutech Corp. , a manufacturer of high-purity chemicals for semiconductors, which strengthens its market position and aligns with its growth strategy. JSR Micro is recognized for its commitment to sustainability and quality, as evidenced by its recent awards for outstanding performance in front-end quality.

📋 Description

• Design, develop, configure, and support enterprise Quality applications such as eQMS, deviation/CAPA, change management, audits, and document management systems • Apply software engineering standards, best practices, and architectural patterns for Quality systems • Provide technical guidance and mentoring to junior engineers and cross-functional team members • Evaluate and recommend approaches to improve Quality system performance and compliance • Ensure systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements • Ensure data integrity, system security, and audit readiness across Quality applications • Translate business and quality process requirements into scalable technical solutions • Provide advanced troubleshooting and root cause analysis for system issues impacting Quality operations • Lead continuous improvement initiatives to reduce manual processes, improve system reliability, and enhance user experience • Lead disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning • Operate with a high degree of autonomy, influence technical direction, and serve as a subject matter expert for software engineering best practices

🎯 Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field • 8–12+ years of professional software engineering or application support experience • 5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry • Proven experience with Quality applications, including commercial or custom-built eQMS platforms • Demonstrated experience executing complex technical initiatives without direct people management responsibility • Experience with enterprise application development and/or configuration, including Python, APIs, SQL, and databases • Strong understanding of Software Development Lifecycle (SDLC) and Agile/DevOps practices in a regulated environment • Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness • Experience with EtQ • Experience with Computer Software Assurance (CSA) • Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations

🏖️ Benefits

• EEO/AA employer actively seeking to diversify its workforce • Equal employment opportunity protections regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status • At-will employment arrangement