Overview
Supplier Quality Engineer Jobs in Westchester, FL at SARACA
Title: Supplier Quality Engineer
Company: SARACA
Location: Westchester, FL
Company Description
SARACA is a global engineering R&D services company serving industries including MedTech, Aerospace, Rail, Automotive, Semiconductor, and Defense. With expertise in medical device development, SARACA is ISO 13485 certified and specializes in areas such as embedded software, mechanical systems, and scientific writing for MedTech compliance. Supported by a global presence and a team of 400+ skilled engineers and consultants, SARACA partners with 25+ Fortune 500 clients to deliver innovative solutions. The company is committed to fostering an inclusive, innovation-driven work culture that supports customer growth and industry leadership.
Role Description
We are actively looking for a Supplier Quality Engineer (SQE) to support supplier quality management and compliance within a regulated medical device manufacturing environment.
This is a great opportunity for professionals experienced in supplier quality, CAPA, and regulatory compliance to contribute to high-impact projects.
Key Responsibilities:
- Develop and maintain supplier quality documentation for products and processes
- Monitor supplier performance to ensure compliance with internal & regulatory standards
- Lead CAPA (Corrective and Preventive Actions) for supplier-related issues
- Support supplier selection, qualification, and evaluation
- Manage supplier change control processes and impact assessments
- Ensure material/component qualification aligns with product requirements
- Maintain documentation for audit readiness and traceability
- Participate in internal and external audits
- Ensure compliance with HSE requirements
Required Skills & Experience
- 6–8 years of experience in Supplier Quality Engineering (SQE)
- Strong knowledge of Medical Device Regulations & Quality Standards (ISO 13485 preferred)
- Expertise in:
- Supplier Quality Management
- CAPA & Root Cause Analysis
- Audits & Compliance
- Strong documentation and regulatory understanding
