Senior Quality Engineer

Job Description

**Supplier Quality Engineer $96k – $130k – Monroe, NC**

**H1B and TN Visa accepted**

**No C2C**

**My Client:**

A global leader in high-quality plastic laboratory products, their company specializes in developing innovative solutions for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical, and biotechnology industries.

**Responsibility:**

* Set detailed guidelines on inspection and testing requirements
* Ensure products adhere to company and industry quality standards
* Develop inspection methods to analyze product quality
* Identify and lead CAPA and process improvement initiatives
* Develop, maintain, and monitor measurement processes to ensure compliance with ISO and FDA regulations
* Collaborate with suppliers to investigate root cause and corrective actions when raw material or component deficiencies are detected
* Monitor and evaluate supplier processes for compliance with purchase order and engineering requirements
* Deploy variation management tools and techniques at select suppliers to mitigate risk
* Audit suppliers and establish supplier quality requirements
* Report on supplier trends for management review and notify management of identified trends
* Design and implement methods for process control, process improvement, testing, and inspection
* Establish and maintain process flow diagrams, workplace layouts, FMEAs, and standardized work instructions

**Job Requirements:**

* Bachelor’s degree in an engineering field or related field. Master’s degree in engineering is preferred
* 3-7 years of experience in a high-volume regulated manufacturing industry in an engineering field
* Working experience with Six Sigma, Lean, and Quality Management Tools
* Broad knowledge of theory and principles of statistics and statistical process control
* Experience with Access Database, Excel, and complaint handling software
* In-depth knowledge of ISO 13485, ISO 14971, and CFR Part 820
* Good understanding of medical device regulation, industry, and international standards
* Strong computer skills in MS Office
* Ability to recognize and manage projects
* Ability to read and understand technical drawings and documents
* Working experience with CAD/SolidWorks
* Ability to work independently and take initiative
* Excellent communication, analytical, troubleshooting, and interpersonal skills
* ASQ Lead Auditor or equivalent training in auditing
* A team player with the ability to work independently