Sr. Supplier Quality Engineer

Job Title

Required Skills & Experience• Bachelor Degree engineering (Master Degree is plus). 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus). • In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ SO 13485 Lead Auditor certified is plus. Experienced in plastic, metal, electronics commodities. Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail Min 20% travel time

Job Description

Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.

Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.

Perform Process Validation, Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.

Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.

Perform Problem solving in the case of FAI and APQP failure.

Deep dive Value Stream mapping across process.

Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.

Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.

Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary.

Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.