Job Details
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 members
Job Requirements
Job 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