Quality Systems Lead - AI, Cybersecurity & Medical Devices

Pro Staff; Acton (MA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Pet Insurance

401(k)

EAP

Commuter/Parking

HSA

AD&D Insurance

Job summary

Pro Staff in Marlborough, MA is seeking a Quality Systems Process Lead to drive improvements in supplier controls, cybersecurity, and regulatory compliance for medical devices.

With 5+ years in Quality Systems and a strong grasp of FDA regulations, ISO 13485, and risk management, you will lead cross-functional teams, develop procedures, and ensure inspection readiness across the organization.

Hybrid work arrangement with 3 days onsite in Marlborough and comprehensive benefits are offered.

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related field preferred.
• 5+ years in Quality Systems, Supplier Quality, Regulatory Compliance in a regulated industry.

Responsibilities

• Lead quality system process improvements related to supplier controls and sourced materials.
• Coordinate cross-functional teams to implement process enhancements and compliance initiatives.
• Develop and maintain quality procedures, work instructions, templates, and documentation.
• Drive projects from planning through implementation while ensuring inspection readiness.

Skills

Quality Systems

Regulatory Compliance

Leadership

Process Improvement

Cross-Functional Collaboration

FDA Regulations

ISO 13485

Cybersecurity

AI in Healthcare

Education

Bachelor's degree in Quality/Engineering/Life Sciences

Job description

Pro Staff in Marlborough, MA is seeking a Quality Systems Process Lead to drive improvements in supplier controls, cybersecurity, and regulatory compliance for medical devices.

With 5+ years in Quality Systems and a strong grasp of FDA regulations, ISO 13485, and risk management, you will lead cross-functional teams, develop procedures, and ensure inspection readiness across the organization.

Hybrid work arrangement with 3 days onsite in Marlborough and comprehensive benefits are offered.