Quality Manager (Onsite)
About The Position
The Quality Manager is responsible for all aspects of the development and implementation of the quality system including preventive and corrective actions, non-conformance control, and continuous improvement and quality system effectiveness. This position serves as the Management Representative for ISO9001, IATF16949, and ISO13485 standards. The role involves leading medical validation efforts, maintaining quality system compliance, conducting training, managing quality staff, and serving as a point of contact for the General Manager and President. The manager will lead the internal audit system, coordinate document control, manage MRB committees, and oversee ISO14001 registration processes.
Requirements
- Bachelor of Arts or Science Degree or Higher
- Job-related experience in quality systems and mechanics
- Experience in a medical and automotive manufacturing environment
- Competency in AIAG core tools, LPA’s and RFMEA’s
Nice To Haves
- Six sigma black belt certification
- Lean experience or certification
- Quality certification
- ASQ membership
Responsibilities
- Development, documentation, implementation and registration of the Quality Systems for ISO9001, IATF16949 and ISO13485
- Serve as the Management Representative for ISO standards
- Lead medical validation efforts including IQ, OQ and PQ activities
- Provide procedural, strategic and policy guidance related to quality systems
- Conduct training and monitoring activities for employees and suppliers
- Maintain authority to stop production due to quality requirements
- Manage and supervise the Quality staff
- Champion the internal audit system and lead customer audits
- Develop performance metrics tracking and reporting systems
- Coordinate with customers regarding quality requirements
- Lead MRB committee and initiate corrective action requests
- Coordinate and administer document control activities
- Set, monitor and report on quality improvement goals
- Lead ISO14001 registration process and environmental controls
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
