Job Title: Supplier Quality Engineer
Location: On-site Melville, New York
Travel Requirement: Approximately 30%
About the Role:
We are seeking a dedicated Supplier Quality Engineer to join our team in Melville, NY. This role is critical in ensuring that our suppliers meet regulatory and quality standards through ongoing audits, monitoring, and root cause analysis. The ideal candidate will bring a proactive approach to managing supplier quality and continuous improvement, especially within FDA-regulated industries. If you have a strong background in medical devices and supplier management, we encourage you to apply.
Key Responsibilities:
1. Conduct regular supplier audits to ensure compliance with applicable regulatory standards and internal quality requirements.
2. Monitor supplier quality performance and drive continuous improvement in supplier processes.
3. Facilitate and perform on-site visits to conduct root cause investigations and implement effective corrective and preventive actions (CAPAs).
4. Create, maintain, and present supplier quality metrics to stakeholders.
5. Maintain thorough and accurate documentation and records related to supplier management and quality assurance.
6. Review customer complaints related to supplier-sourced components and conduct associated product investigations.
7. Perform medical device reporting (MDR) assessments and manage related documentation.
8. Develop and implement sampling plans to evaluate and report on product quality and reliability data.
9. Lead or support initiatives to enhance the Quality Management System (QMS), including training and development activities.
10. Identify quality issues and drive cross-functional problem-solving initiatives.
11. Demonstrate continuous improvement efforts to enhance product quality and manufacturing processes.
Qualifications:
* Bachelor's degree in Engineering or a related technical discipline (required; Mechanical, Biomedical, or Industrial Engineering).
* 5+ years of experience in quality functions within a manufacturing environment, preferably in an FDA-regulated industry.
* Direct experience in supplier quality management and auditing.
* Strong knowledge of FDA regulations, including cGMP, 21 CFR Part 820, and ISO 13485:2016.
* Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
* Excellent communication and interpersonal skills with a collaborative, team-oriented mindset.
* Demonstrated problem-solving and decision-making abilities, with a logical and analytical approach.
Additional Information:
* This is a full-time, on-site position based at our Melville, NY facility.
* Approximately 30% travel is required, including domestic and occasional international supplier visits.
#J-18808-Ljbffr