> Markdown version of [/jobs/ext/1346625-quality-engineer-controlled-substance-program-lead](https://www.wearedevelopers.com/jobs/ext/1346625-quality-engineer-controlled-substance-program-lead). 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). --- # Quality Engineer/Controlled Substance Program Lead - **Company:** Thermo Fisher Scientific Inc. - **Location:** Middletown, VA, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Document Management Systems, Failure Mode Effects Analysis, Microsoft Office - **Published:** July 19, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=28458c7e01f6569b ## About the Role * Advanced degree with 3+ years of experience in Quality Assurance within a regulated industry OR * Bachelor's degree with 5+ years of experience in Quality Assurance within a regulated industry (pharmaceutical, medical device, biotech, or related field) * Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field Preferred Certifications * ASQ Certifications such as: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Technical & Regulatory Expertise Strong knowledge of: * cGMP requirements * ISO 13485 / ISO 9001 standards * DEA regulations * FDA, EMA, and other applicable regulatory requirements Experience with quality systems and processes including: * CAPA and deviation management * Change control * Risk management and FMEA * Document control * Internal and external auditing * Validation and qualification protocols Skills & Competencies * Advanced problem-solving and root cause analysis skills * Strong project management capabilities * Excellent verbal and written communication skills * Proficiency with quality management systems/software and Microsoft Office * Knowledge of statistical analysis and quality tools * Ability to work independently and collaboratively in cross-functional environments * Strong attention to detail while maintaining a strategic, big-picture perspective * Excellent interpersonal and stakeholder management skills Additional Requirements * Ability to travel up to 25% as needed * Must be legally authorized to work in the United States without sponsorship. * Must be able to pass a comprehensive background check, which includes a drug screening. ## Description Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), As a Quality Engineer III and Controlled Substance Program Lead, you'll help ensure quality excellence and regulatory compliance to DEA across manufacturing operations. You'll help ensure our products meet the highest Quality and regulatory Compliance standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO and DEA compliance. The role is responsible for overseeing the Controlled Substance Program to ensure compliance with applicable regulatory requirements and internal quality standards. In addition, the position collaborates cross-functionally with multiple teams to investigate and resolve quality issues, conduct risk assessments, manage CAPA activities, support internal and external audits, and drive continuous quality improvement initiatives. The role requires strong analytical, problem-solving, and communication skills to effectively interface with internal stakeholders, customers, and regulatory agencies while helping establish, maintain, and enhance quality systems and compliance practices. ## Related Videos - [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build) - [Same Tower, New Confusion: The Tower of Babel 2.0](https://www.wearedevelopers.com/videos/100101-same-tower-new-confusion-the-tower-of-babel-2-0) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Quantum DevOps - Enabling Industrial Engineering](https://www.wearedevelopers.com/videos/100282-quantum-devops-enabling-industrial-engineering) - [Building an AI-Ready Content Lake: Scaling RAG and Document AI Beyond Demos](https://www.wearedevelopers.com/videos/1977-building-an-ai-ready-content-lake-scaling-rag-and-document-ai-beyond-demos) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) ## Related Articles - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [How to Write a CV and Interview if You Don't Fully Qualify For The Job](https://www.wearedevelopers.com/magazine/183-how-to-write-a-cv-and-interview-if-you-don-t-fully-qualify-for-the-job) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [From developer to manager – what does it take to become an engineering manager?](https://www.wearedevelopers.com/magazine/42-from-developer-to-manager-what-does-it-take-to-become-an-engineering-manager)