Senior Supplier Quality Engineer, MedTech PCBA

Forj Medical; Saint Paul (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Forj Medical is seeking a Senior Supplier Quality Engineer to oversee our supplier quality base for complex electronic and software medical devices. You will provide technical leadership, drive design and process improvements, and manage supplier selection, audits, and issue resolution.

The role demands 6+ years in supplier quality plus 3+ years in FDA-regulated medical devices, with PCB/PCBA experience and strong problem-solving abilities. Travel ~10% possible.

Qualifications

• Bachelor's degree in engineering required.
• 6+ years in supplier quality, component engineering, or supplier support.
• 3+ years in FDA-regulated medical devices.
• Experience with PCB assemblies and PCBs.
• Experience with process qualification and validation for medical devices.
• Experience with lean manufacturing and problem solving.
• Ability to communicate technical issues across functions.
• Lead auditor training/certification (ISO 13485 and/or FDA QSR) preferred.

Responsibilities

• Lead issue investigations and resolutions with direct material suppliers.
• Oversee supplier qualification, audits, and problem resolution.
• Support supplier management to ensure materials meet specs.
• Support quality system audits and supplier-related CAPA and SCAR activities.
• Collaborate with strategic suppliers to improve cost of quality and lead times.

Skills

Root cause analysis

Technical communication

Lean manufacturing

FDA regulated devices

Process risk management

Education

Bachelor's degree in engineering

Tools

ERP/MRP systems

Job description

Forj Medical is seeking a Senior Supplier Quality Engineer to oversee our supplier quality base for complex electronic and software medical devices. You will provide technical leadership, drive design and process improvements, and manage supplier selection, audits, and issue resolution.

The role demands 6+ years in supplier quality plus 3+ years in FDA-regulated medical devices, with PCB/PCBA experience and strong problem-solving abilities. Travel ~10% possible.