Regulatory Compliance Engineer

5 days ago


Buffalo Grove, Illinois, United States Sterling Engineering Inc. Full time

Sterling Engineering Inc. requires a highly skilled Regulatory Compliance Engineer to ensure our medical devices meet the highest regulatory standards. As a key member of our quality department, you will play a pivotal role in maintaining compliance with ISO and FDA QSR quality systems.

**Key Responsibilities:**
* Collaborate with cross-functional teams to investigate and resolve customer complaints, leveraging your problem-solving skills and industry expertise.
* Evaluate and manage supplier performance, fostering strong partnerships and ensuring mutual understanding of specified requirements.
* Conduct supplier quality evaluations, audits, and implement quality agreements to maintain compliance and foster continuous improvement.
* Support and maintain compliance with ISO and FDA QSR quality systems, as well as company policies and initiatives.
* Identify and execute continuous improvement projects, leveraging Six Sigma tools and methodologies.
**Requirements:**
* Bachelor's degree in Engineering, Science, or a related field
* 3+ years of experience in a Quality position, preferably in the Medical Device industry (ISO 13485)
* Proven expertise in technical writing, IQ/OQ/PQ, and equipment validation
* Excellent communication skills and fluency in English
* Proficiency in advanced mathematical concepts and intermediate statistical (SPC) knowledge
* Six Sigma experience, training, or certification is preferred. SAP experience is an added advantage.
**Estimated Salary:** $95,000-$115,000 based on location and industry standards



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