Job Title:  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 manufactuirng 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 dispostions (UAI, Scrap, RTV, etc.) of NCRs.
• Perform investigations on quality related issues, including CAPA, Complaints, Root Cause Analysis, etc. as required.
• Review/approval of documentaion 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, 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.
• Other responsibilities as required.

EDUCATION and/or EXPERIENCE
Required:

• Bachelor’s Degree (BA/BS) in Quality or Engineering discipline
• Zero (0) to five (5) years of Quality Engineering experience
• Knowledge and experience with ISO 13485:2016 and FDA QSR 21 CFR:820
• Working knowledge of Microsoft office applications

Desired:

• Experience in a medical device manufacturing environment
• ASQ certification such as, but not limited to, Certified Quality Engineer (CQE)
• Knowledge of statistical programs such as Minitab
• Working knowledge of Micro Vu vision system programming

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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.

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.