Overview
Supplier Quality Engineer $96k - $130k - Monroe, NC
H1B and TN Visa accepted
No C2C
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.
Responsibilities
- 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
Qualifications
Bachelor's degree in an engineering field or related field. Master's degree in engineering is3-7 years of experience in a high-volume regulated manufacturing industry in an engineering fieldWorking experience with Six Sigma, Lean, and Quality Management ToolsBroad knowledge of theory and principles of statistics and statistical process controlExperience with Access Database, Excel, and complaint handling softwareIn-depth knowledge of ISO 13485, ISO 14971, and CFR Part 820Good understanding of medical device regulation, industry, and international standardsStrong computer skills in MS OfficeAbility to recognize and manage projectsAbility to read and understand technical drawings and documentsWorking experience with CAD / SolidWorksAbility to work independently and take initiativeExcellent communication, analytical, troubleshooting, and interpersonal skillsASQ Lead Auditor or equivalent training in auditingA team player with the ability to work independentlyJ-18808-Ljbffr