Quality Engineer - Medical Devices, QMS & CAPA

Insight Global; Raynham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a Quality Engineer to support the QMS and ensure ISO13485 compliance. You will partner with management to uphold the QMS and provide shop floor engineering support to maximize uptime and high product quality.

The role requires 3–5 years of quality engineering experience in medical devices, with strong knowledge of CAPA, MRB, FAI and metrology tools. Experience with audits and ERP systems is a plus. Fluency in English and proficiency with MS Office are expected.

Qualifications

• 3–5 years of quality engineering experience in medical device components.
• Strong understanding of ISO13485 QMS and regulatory requirements.
• Experience with CAPA, MRB, NCMR, FAI and KPI improvement.
• Proficiency in metrology tools and reading drawings (GD&T).
• Experience with audits/inspections is a plus.

Responsibilities

• Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness.
• Shop floor support for troubleshooting, root cause analysis, support production uptime with engineering.
• Lead CAPA ownership and MRB processes where applicable.
• Support the Equipment Qualification and Validation Process (IQ, OQ and PQ).
• Drafts and executes protocols with Engineering.
• Nonconforming Material System (NCMR) ownership and MRB involvement.
• Performs First Article Inspections (FAI) with QC personnel.
• Supports Measurement System Analysis (Gage R&R) where applicable.
• Supports KPI improvements and business objectives.
• Supports ASL evaluations, reporting and feedback.
• Creates and edits SOPs, Work Instructions and forms.
• Provides input to FMEAs / Risk Management.
• Performs product quality inspections as needed.
• Performs calibration of measuring and monitoring equipment.
• Provides training as needed.

Skills

Quality engineering

ISO13485

CAPA

Gage R&R

First Article Inspection

Minitab

GD&T

English communication

ERP systems

MS Office

Tools

QMS software

Visio

Word

Excel

PowerPoint

Job description

Insight Global is seeking a Quality Engineer to support the QMS and ensure ISO13485 compliance. You will partner with management to uphold the QMS and provide shop floor engineering support to maximize uptime and high product quality.

The role requires 3–5 years of quality engineering experience in medical devices, with strong knowledge of CAPA, MRB, FAI and metrology tools. Experience with audits and ERP systems is a plus. Fluency in English and proficiency with MS Office are expected.