Sr Supplier Qual Engineer
Manufacturing
Job Description
Job Description
Job Title: Sr Supplier Qual Engineer
Location: Billerica, MA (Fully Onsite)
Duration: 6 Months, with potential extension
Schedule: 40 hours/week
Job Description:
We are seeking a Senior Supplier Quality Engineer with medical device industry experience to support Sphere-9 Catheter Production. The role involves supplier qualification, product/component qualification, validation, and ensuring compliance with quality standards.
Key Responsibilities:
- Qualify suppliers and ensure product/component quality.
- Lead product acceptance strategies and incoming inspection activities.
- Perform Test Method Validation (TMV), equipment validation, and process validation.
- Manage supplier change requests, nonconformances (NCMRs), and CAPA.
- Support Approved Supplier List (ASL) activities and supplier performance monitoring.
- Drive process capability improvements and resolve supplier quality issues.
Requirements:
- Bachelor's degree in Engineering, preferably Mechanical or Electrical.
- 3–6 years of relevant experience in Supplier Quality Engineering.
- Medical device industry experience is required.
- Hands-on experience in product/component qualification, validation, and process capability.
- Strong understanding of supplier quality processes and corrective actions.