Senior Medical Device Manufacturing Quality Engineer

Axoft; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Parental leave

Flexible paid time off

Job summary

Axoft is seeking a Senior Manufacturing Quality Engineer to support scale-up of regulated manufacturing for implantable brain-machine interface technology. You will implement practical, compliant quality systems and collaborate with Manufacturing, Engineering, and Operations to enable reliable production.

Reporting to the Director of Quality Assurance, you will drive process controls, documentation, inspection strategies and QC workflows suitable for Class II/III medical devices, with hands-on

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5–7 years in manufacturing quality or QA in medical devices.
• Experience with Class II/III devices and FDA ISO 13485 environments.

Responsibilities

• Serve as primary Quality partner for manufacturing within the QMS.
• Define, qualify, and improve production processes and control strategies.
• Plan IQ/OQ/PQ activities and ensure audit-ready documentation.
• Develop and review manufacturing docs, SOPs, and sampling plans.

Skills

FDA regulations

Quality systems

Process validation

Documentation

Root cause analysis

Cross-functional collaboration

Project management

Regulatory compliance

Education

Bachelor’s degree in Engineering

Tools

QMS software

MRP/ERP systems

Job description

Axoft is seeking a Senior Manufacturing Quality Engineer to support scale-up of regulated manufacturing for implantable brain-machine interface technology. You will implement practical, compliant quality systems and collaborate with Manufacturing, Engineering, and Operations to enable reliable production.

Reporting to the Director of Quality Assurance, you will drive process controls, documentation, inspection strategies and QC workflows suitable for Class II/III medical devices, with hands-on