Quality Engineer - Medical Devices | ISO 13485 & FDA

AMETEK, Inc.; Mansfield (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

AMETEK, Inc. through Paragon Medical in Mansfield, MA seeks a Quality Engineer to develop and maintain QA functions, ensuring defects are identified, documented, tracked, and resolved across engineering and manufacturing. You will report to the Quality Manager.

The role supports GMP compliance, CAPA investigations, NCR processing, and document control while collaborating with cross-functional teams to drive quality excellence at the Mansfield site.

Qualifications

• Bachelor’s degree in Quality or Engineering.
• 2+ years of quality engineering experience.
• Experience with ISO 9001:2015 or ISO 13485:2016.
• Knowledge of FDA QMSR 21 CFR 820 desired.

Responsibilities

• Create, implement and revise QA inspection plans and documents to maintain ISO/FDA compliance and QMS improvements.
• Drive continuous quality improvements including better inspection methods.
• Coordinate NCR reviews and dispositions for incoming, in-process and final inspections.
• Investigate quality issues, lead CAPA and root cause analyses.
• Review/approve documentation via Pre-Production Release or ECO.
• Interface with customers, suppliers, project teams, and regulatory bodies.

Skills

Quality engineering

Regulatory compliance

Process improvement

CAPA/NCR handling

Statistical analysis

FDA QMSR 21 CFR 820 knowledge

ASQ CQE (desired)

Minitab

Micro Vu vision system

AI tooling for productivity

Education

Bachelor’s Degree in Quality or Engineering

Tools

Minitab

Micro Vu Vision System

Job description

AMETEK, Inc. through Paragon Medical in Mansfield, MA seeks a Quality Engineer to develop and maintain QA functions, ensuring defects are identified, documented, tracked, and resolved across engineering and manufacturing. You will report to the Quality Manager.

The role supports GMP compliance, CAPA investigations, NCR processing, and document control while collaborating with cross-functional teams to drive quality excellence at the Mansfield site.