Quality Engineer

We are searching for a Quality Engineer who under general direction will create and maintain Quality Assurance functions, procedures and practices within the company. You will ensure that quality issues and defects are appropriately identified, documented, tracked, and resolved. You will support both engineering and manufacturing activities at the Mansfield site and report to the Quality Manager.
KEY RESPONSIBILITIES:
Create, implement and revise Quality inspection plans, procedures and documents in support of engineering (NPD and NPI) and manufacturing to maintain compliance with ISO/FDA regulatory requirements and Quality Management System (QMS) improvement.
Continuous improvement activities as they apply to Quality, such as, but not limited to, improved inspection methods, etc.
Coordinate review and processing of project related NCRs issued for incoming, in-process and final inspections. Work with Product Development Team or Manufacturing Engineering in providing appropriate dispositions (UAI, Scrap, RTV, etc.) of NCRs.
Perform investigations on quality related issues, including CAPA, Complaints, Root Cause Analysis, etc. as required.
Review/approval of documentation via Pre-Production Release or ECO.
Interface with customers, suppliers, Project Team and Client Regulatory to resolve quality matters, as required.
Provide necessary technical support to other departments such as engineering, sustaining engineering, and manufacturing activities.
Work with all departments in implementing and complying with Quality Systems and GMP requirements.
Support to Document Control as required (ie: review of lot release records, etc.).
Assist in training inspection and production employees as required.
Execute tasks assigned by the Project Manager when assigned to a Project Team.
Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.
Other responsibilities as required.
POSITION REQUIREMENTS:
Bachelor’s Degree (BA/BS) in Quality or Engineering discipline with at least 2 years of quality engineering required.
Working knowledge of ISO 9001:2015 or ISO 13485:2016 required.
Working knowledge of Microsoft office applications required.
Experience in a medical device manufacturing environment is desired.
Inspection methods using vision system, calipers, micrometers and other related tools desired.
Knowledge and experience with FDA QMSR 21 CFR:820 desired.
ASQ certification such as, but not limited to, Certified Quality Engineer (CQE) is desired.
Knowledge of statistical programs such as Minitab desired.
Working knowledge of Micro Vu vision system programming desired.
Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs.The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.
Physical Demands:
Sitting, standing, walking, grasping, climbing, stooping, kneeling, or crawling as required.
Occasional lifting, carrying, pushing, and pulling up to 25 lbs.
Work Environment:
Office environment with low noise levels and manufacturing plant as needed.
Paragon Medical, a business of AMETEK, Inc, serves as a strategic partner in medical device manufacturing, offering an end-to-end supply chain solution from initial concept and product development, to verification and validation testing, to final production, assembly, and ongoing strategic demand planning.
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