The Supplier Quality Manager is responsible to demonstrate ability to isolate and define problems; direct and maintain Supplier Management Program. Develop the Supplier audit schedule and ensure supplier audits are completed as scheduled. Timely follow-up on supplier quality issues. Maintain control of quality costs for the supplier management program including incoming sampling and personnel costs. Ensure full compliance with policies, procedures, QSR and ISO. Assume responsibility for proper documentation and revision control to meet FDA and company established standards. Solve the manufacturing and Quality problems to support de manufacturing operation related with the supplier issues and responsible for follow up of the Quality improvements with them.
Participate in third party audits such as corporate, ISO and FDA. Design methods and procedures to improve inspection and workflow in the incoming inspection area. Qualify new suppliers and re-qualify as required (due to facility moves, process/tooling changes, etc. Work with suppliers to improve processes and quality system. Initiate lean thinking methods to improve inspection and workflow in the inspection areas.
Familiarized/Experience with Internal Audit Matrix:
Audit Plan. Opening and Closing Meeting. Internal Audit Report. Quality Management System Elements (Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement. Internal Quality Audits, etc.QMS Audits Techniques
ISO 13485: 2003 “Medical Devices” Quality Management Systems Requirements for Regulatory Purpose”. 21 CFR part 820 Title -- Food and Drugs Chapter I – Food and Drug Administration Department of Health and Human Services Part 820 – Quality System Regulation. J-PAL MO No. 169 – Japan Pharmaceutical Affairs Law Ministerial Ordinance. Brazil Resolution RDC 59/200 (ANVISA – Resolution – Collegiate Board Resolution No. 59). MDD 93/42 EEC (European Community Medical Device Directive). Geometric Dimensioning & Tolerance (MSA-Measurement System Analysis). Calibration Systems.
Competences: Microsoft Office. Bilingual, able to communicate both verbally and in writing in English. Good communications skills, dynamic, positive attitude with good interpersonal and organizational skills, proficient, ability to solve problems, responsible, ability to work under pressure. High level of leadership and capable of manage different projects at the same time.