Support activities relating to the management of clientsSupplier Quality program. Assist the Procurement, Quality Assurance, Manufacturing and Engineering departments with the day to day issues relating to Supplier certification, validation and Quality. Pursue continuous process and yield improvement throughout Supplier base.
35% Manages assigned Suppliers thru the review of Supplier performance data, communication of Supplier performance with Supplier, driving improvements in Supplier' s delivered Quality, evaluation and validation of Supplier proposed changes and completion of Supplier improvement or qualification audits as needed. Some travel will be required.
25% Daily Quality support for issues arising in incoming inspection, MRB and on the production lines.
25% Supports the New Product Introduction, Cost Reduction, and part resourcing activities thru the completion of Supplier outsource validations of designed parts/assemblies. Collect, review, summarize validation objective evidence, write validation reports and issue Supplier corrective actions as appropriate.
5% Works independently or part of a team to conduct internal investigations for identified nonconformance' s to root cause and implementation of corrective or preventative action.
5% Supports the R&D, component and purchasing organizations with the identification and selection of vendors in the new product development process.
5% Other duties as required, to include internal process improvements.
Minimum 5 years experience in a Quality Engineering support role for electronics, metals, plastic injection molded parts, cables and electro-mechanical assemblies.
Experience with demonstrated improvement of Supplier Quality and a strong background in Supplier auditing for continuous improvement.
Experience using problem solving tools to drive to root cause.
Working knowledge of manufacturing processes (PCB fabrication, PCBA and Cable assembly, injection molding, machining, etc.).
Development and execution of validation plans including IQ, OQ, PQ protocols utilizing various
Quality tools such as documentation review, process flow maps, control charts and PFMEA both at client and the Supplier base.
Background in product structure, BOMs and MRP systems.
Strong background with ISO13485, IS09001, FDA 21 CFR Part 820.
Proficient in most common PC based applications (Word, Excel, Powerpoint, Project, Visio etc.). Proficiency with Agile document management system desired.
Minimum of a Bachelor' s Degree in engineering or other technical discipline.
Advanced degree and/or applicable certifications (ASQ CQA or CQE, 6? Black Belt) desired.