Quality Systems Manager

4 weeks ago


Fairfield, United States Synerfac Full time

Details: Duties and Responsibilities:* Is the company Management Representative responsible for implementing,establishing, and maintaining the company quality system in accordance with ISO13485/ 21CFR820 and other specifications as required, ensures the company meets any otheradditional customer specific requirements. Represents the company as the liaison withexternal parties regarding the company quality system and its" capabilities.* Responsible to facilitate management review meetings and report on the performanceof the quality system and its" metrics.* Is a certified Lead Auditor responsible for the company internal audit program incompliance with ISO13485 / 21CFR820 and other specifications as required. ConductsQMS, Process and Final Product Audits.* Manage Internal Corrective Actions (ICAR): manage log, issue ICARS, assist in correctiveactions and verify effectiveness of corrective actions through auditing.* Interfaces with customers, sales, manufacturing, and engineering to resolve quality andcontractual issues.* Manages the corrective action process in molding, including facilitating and leadingcorrective action teams, maintains dialogue and correspondence with customers andsuppliers, controls records regarding corrective actions. Assists and facilitates correctiveaction teams in stamping upon request.* Facilitates company quality system related training programs, gives on the jobinstruction and presentations as needed. Coordinates diverse training needs withoutside consultants. Obtains outside funding for training (NJ Customized Training) asneeded.Job RequirementsDetails: Qualifications:* 5 years" experience in Quality Control/Assurance in a tight tolerance industry with amedical device or life sciences customer base.* Needs a thorough understanding of automotive and medical industry qualityrequirements (APQP, FMEA, Process Flows, Control Plans, Measurement SystemAnalysis).* Requires training in and thorough understanding of ISO13485 / 21CFR820.* Maintains and is responsible for the company"s document control system. Responsiblefor the maintenance of the Master Databases on the company network used to controlcompany documents.* Maintains and controls the company ISO13485 / 21CFR820 Training records for allcompany team members. Responsible for the maintenance of Master trainingdatabases on the company network.



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