> Markdown version of [/jobs/ext/2442809-lead-senior-quality-engineer](https://www.wearedevelopers.com/jobs/ext/2442809-lead-senior-quality-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).

---

# Lead Senior Quality Engineer

- **Company:** Actalent
- **Location:** Longmont, CO, United States
- **Experience:** Expert
- **Salary:** $110,240.0 - $149,760.0
- **Contract:** Temporary to permanent
- **Skills:** Integrated Development Environments, Statistical Process Control (SPC)
- **Published:** August 6, 2026
- **Apply:** https://www.techcareers.com/job.asp?id=3343332241&tx=KP505PFK&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54

## About the Role

* Bachelor's degree in Engineering or related technical field.
 * 5+ years in medical device quality management.
 * 3+ years managing or leading quality teams.
 * Hands-on experience with ISO 13485:2016 and FDA 21 CFR 820.
 * Direct ownership of design controls and DHF.
 * Experience leading CAPA, NCR, and root cause investigations.

Additional Skills & Qualifications

 * Class II / Class III medical device experience.
 * Exposure to implantable devices.
 * Statistical Process Control (SPC).
 * Experience supporting FDA inspections and notified body audits.
 * Master's degree in Engineering or Quality.

Work Environment

You will work in a regulated medical device manufacturing and development environment. This role requires onsite presence due to inspection, manufacturing, and team leadership needs. You must adhere to quality system, documentation, and audit protocols.

## Description

We are seeking an experienced Lead Design Assurance Quality Engineer to spearhead quality strategies for Class II and III medical device development and manufacturing. This role entails ownership of design quality assurance, regulatory compliance, and continuous improvement while leading a multi-disciplinary quality team. You will collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure products are compliant, audit-ready, and adhere to the highest patient safety standards., * Own and maintain compliance to ISO 13485:2016 and FDA 21 CFR Part 820 across development and manufacturing.

 * Lead design quality assurance activities pre- and post-production, ensuring complete, audit-ready design history files.
 * Drive investigations into nonconformances, deviations, and out-of-tolerance results; lead root cause analysis and corrective/preventive actions.


## Related Videos

- [Alibaba Big Data and Machine Learning Technology](https://www.wearedevelopers.com/videos/37-alibaba-big-data-and-machine-learning-technology)
- [Inside the Mind of an LLM](https://www.wearedevelopers.com/videos/1617-inside-the-mind-of-an-llm)
- [Why Your Best Mediors Never Become Seniors (And How to Fix It)](https://www.wearedevelopers.com/videos/2108-why-your-best-mediors-never-become-seniors-and-how-to-fix-it)
- [Walking into the era of Supply Chain Risks](https://www.wearedevelopers.com/videos/376-walking-into-the-era-of-supply-chain-risks)
- [GenAI Unpacked: Beyond Basic](https://www.wearedevelopers.com/videos/1526-genai-unpacked-beyond-basic)
- [What Developers Get Wrong About Application Quality](https://www.wearedevelopers.com/videos/233-what-developers-get-wrong-about-application-quality)

## 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)
- [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)
- [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)
- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)
- [Software Engineer Salary London](https://www.wearedevelopers.com/magazine/252-software-engineer-salary-london)
- [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)