Quality Systems Manager

2 weeks ago


East Hanover, United States Synerfac Full time

Our client in Fairfield, NJ is searching for an experienced Quality Systems Manager for their Medical Manufacturing Division.Job Description:- Oversee all aspects of the organization's quality system and improvement efforts- Developing, implementing, and administrating the program, training, and coaching employees- Responsible for establishing policies and procedures at all levels to ensure quality improvement efforts will meet or exceed internal and external customer needs and expectations - Responsible for dealing with customers and suppliers on quality or performance issues- Responsible to facilitate management review meetings and report on the performance of the quality system and its metrics - Manage Internal Corrective Actions (ICAR) and verify effectiveness of corrective actions through auditing- Responsible for the maintenance of the Master Databases on the company network- Maintains and controls the company ISO13485 / 21CFR820 Training records for all company team membersJob RequirementsJob Requirements:- 5 years or more experience in Quality Control/Assurance in a tight tolerance industry with a medical device or life sciences customer base- Thorough understanding of automotive and medical industry quality requirements (APQP, FMEA, Process Flows, Control Plans, Measurement System Analysis) - Certified Lead Auditor responsible for the company internal audit program in compliance with ISO13485 / 21CFR820



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