Medical Device Quality Engineer - QA & CAPA

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

Job summary

AMETEK, Inc., via Paragon Medical, seeks a Quality Engineer in Mansfield, MA. Under general direction you will create and maintain Quality Assurance functions, procedures and practices to identify, document, track, and resolve quality issues, supporting both engineering and manufacturing and reporting to the Quality Manager.

You will lead QA inspection plans, participate in ISO and FDA QMSR compliance, manage NCRs, CAPA and root‑cause analyses, and collaborate with customers, suppliers and

Qualifications

• Bachelor’s degree in Quality or Engineering; 2+ years in quality engineering.
• Experience with ISO 9001:2015 or ISO 13485:2016.
• Experience in medical device manufacturing is desirable.
• Familiarity with FDA QMSR 21 CFR 820 desired.
• ASQ CQE desirable.

Responsibilities

• Create and revise QA inspection plans and documents to meet ISO/FDA/QMS.
• Lead continuous improvement of quality processes.
• Review NCRs and provide dispositions with engineering teams.
• Investigate quality issues with CAPA and root-cause analysis.
• Support documentation control and training.
• Interface with customers, suppliers, and regulatory bodies.
• Assist in AI-driven productivity improvements.

Skills

Quality engineering

Regulatory compliance

CAPA

Root cause analysis

AI tools

GMP

Statistical analysis

Education

Bachelor’s degree in Quality or Engineering

Tools

Minitab

MS Office

Micro Vu

Job description

AMETEK, Inc., via Paragon Medical, seeks a Quality Engineer in Mansfield, MA. Under general direction you will create and maintain Quality Assurance functions, procedures and practices to identify, document, track, and resolve quality issues, supporting both engineering and manufacturing and reporting to the Quality Manager.

You will lead QA inspection plans, participate in ISO and FDA QMSR compliance, manage NCRs, CAPA and root‑cause analyses, and collaborate with customers, suppliers and