Senior Quality Engineer
Listed on 2026-02-16
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Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Senior Quality Engineer | High-Impact Role
Are you passionate about driving quality, leading process improvements, and ensuring products meet the highest regulatory standards? We are seeking a Senior Quality Engineer to play a critical role in strengthening supplier quality, enhancing inspection methods, and supporting continuous improvement initiatives within a high-volume, regulated manufacturing environment.
If you thrive in a collaborative setting and enjoy solving complex quality challenges, this opportunity offers strong visibility, ownership, and the ability to make a measurable impact.
Visa Sponsorship is not provided
What You’ll Do- Establish detailed inspection and testing requirements to ensure product excellence
- Lead CAPA investigations and drive sustainable process improvements
- Develop and implement process controls, testing methods, and inspection strategies
- Partner with suppliers to identify root causes and implement corrective actions
- Audit suppliers and define supplier quality requirements
- Deploy variation management tools to mitigate risk across the supply chain
- Monitor supplier performance trends and present insights to leadership
- Maintain process flow diagrams, FMEAs, and standardized work instructions
- Ensure compliance with ISO standards, FDA regulations, and medical device requirements
- Bachelor’s degree in Engineering or related field (Master’s preferred)
- 3–7 years of quality engineering experience in a high-volume regulated manufacturing environment
- Strong knowledge of ISO 13485, ISO 14971, and CFR Part 820
- Hands-on experience with Six Sigma, Lean, SPC, and quality management tools
- Proven background in supplier quality, auditing, and process improvement
- Ability to interpret technical drawings and engineering documentation
- Experience with CAD/Solid Works, Access, and Excel preferred
- ASQ Lead Auditor certification (or equivalent auditing training) is a plus
- Excellent analytical, troubleshooting, and communication skills
✅ High visibility with leadership and cross-functional teams
✅ Opportunity to influence supplier quality strategy
✅ Work on products that demand precision and regulatory excellence
✅ Strong career growth potential
If you’re ready to take the next step in your quality engineering career and make a meaningful impact, I’d love to connect.
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