Quality Engineer II – Medical Devices (Hybrid, PMA-ready)

Pragmatic; Massachusetts; On-site; USD 85,000 - 125,000; Full time

Job summary

Pragmatic is seeking a Quality Engineer II in Bedford, MA, to work on-site four days a week with one day from home. The role spans incoming inspection to design controls for new programs within a small team, supporting CAPA, nonconformances, and regulatory compliance.

You will help maintain quality systems for ISO 13485 and FDA requirements while partnering with manufacturing and R&D to ensure robust process controls and ongoing improvement across the product portfolio.

Qualifications

• Two to four years in a regulated environment (medical/device/biotech/diagnostics).
• Understanding of ISO 13485 and FDA QMSR or 21 CFR Part 820.
• Bachelor's degree in engineering or related scientific discipline.
• Strong documentation and attention to detail.
• Ability to work with minimal supervision across multiple disciplines.

Responsibilities

• Build and maintain inspection protocols and quality standards for materials and processes.
• Provide real-time quality support on the manufacturing floor with investigations and root cause analysis.
• Support verification and validation for new product development and sustaining programs.
• Manage CAPA, nonconformance, and complaint handling per ISO and FDA requirements.
• Track quality metrics and collaborate with manufacturing and R&D to improve processes.

Skills

Regulated environment experience

ISO 13485 knowledge

Bachelor's degree in engineering

Attention to detail

Independent work

Education

Bachelor's degree in Engineering

Job description

Pragmatic is seeking a Quality Engineer II in Bedford, MA, to work on-site four days a week with one day from home. The role spans incoming inspection to design controls for new programs within a small team, supporting CAPA, nonconformances, and regulatory compliance.

You will help maintain quality systems for ISO 13485 and FDA requirements while partnering with manufacturing and R&D to ensure robust process controls and ongoing improvement across the product portfolio.