Medical Device Quality Engineer — QMS & CAPA Lead

Insight Global; Norwood (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Insight Global is seeking a Quality Engineer to support the effectiveness of the Quality Management System (QMS) and ensure ISO13485:2016 compliance across manufacturing activities. The role partners with management to uphold QMS adherence and provides critical product and process support on the shop floor to maximize uptime and product quality.

The ideal candidate will have 3–5 years in quality engineering for medical devices, strong knowledge of CAPA, MRB, FAI, Gage R&R, and experience with

Qualifications

• 3 to 5 years of quality engineering experience in medical device manufacturing.
• Full understanding of a QMS and conformance to ISO13485:2016.
• Experience with CAPA, MRB, FAI and calibration.
• Ability to read drawings and GD&T.
• Strong English communication skills (verbal and written).
• Experience with audits/inspections is a plus.

Responsibilities

• Maintain and ensure effectiveness of the QMS.
• Shop floor troubleshooting and uptime support with engineering.
• Lead CAPA ownership and MRB processes where applicable.
• Support Equipment Qualification and Validation (IQ/OQ/PQ).
• Draft and execute protocols with Engineering.
• Perform FAI with QC personnel.
• Support KPI improvements and business objectives.
• Create/edit SOPs, work instructions and forms.
• Assist ASL evaluations and supplier feedback.
• Provide training and other duties as assigned.

Skills

QMS knowledge

ISO13485:2016

Root cause analysis

Metrology proficiency

GD&T reading

English communication

Audits experience

ERP familiarity

Minitab

MS Office

Tools

ERP system

QMS software

Minitab

Microsoft Office

Job description

Insight Global is seeking a Quality Engineer to support the effectiveness of the Quality Management System (QMS) and ensure ISO13485:2016 compliance across manufacturing activities. The role partners with management to uphold QMS adherence and provides critical product and process support on the shop floor to maximize uptime and product quality.

The ideal candidate will have 3–5 years in quality engineering for medical devices, strong knowledge of CAPA, MRB, FAI, Gage R&R, and experience with