Quality Systems Lead: Process Excellence & Compliance

Advantage Technical; Acton (MA); Hybrid; USD 108,000 - 132,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

Health Savings Account (HSA)

AD&D Insurance

Pet Insurance

Job summary

Advantage Technical Marlborough, MA is hiring a Quality Systems Process Lead (QMS) to shape quality systems and supplier processes in a medical device manufacturing environment. The role emphasizes leadership, cross-functional collaboration, and regulatory compliance.

The position involves guiding cybersecurity, AI-enabled technologies, and digital health product quality initiatives while coordinating across departments to ensure inspection readiness and compliance.

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.
• Support cybersecurity, AI-enabled technologies, software, and digital health products initiatives.
• Develop and maintain quality procedures, work instructions, and templates.
• Coordinate cross-functional teams to implement process enhancements and regulatory initiatives.
• Evaluate supplier lifecycle management, risk management, change controls, and qualification processes.
• Partner with business leaders to strengthen quality and regulatory compliance.

Skills

Quality Systems

Regulatory Compliance

Supplier Quality

Process Improvement

Leadership

Cross-functional Collaboration

Education

Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs

Tools

FDA regulations knowledge

ISO 13485 knowledge

ISO 14971 knowledge

Job description

Advantage Technical Marlborough, MA is hiring a Quality Systems Process Lead (QMS) to shape quality systems and supplier processes in a medical device manufacturing environment. The role emphasizes leadership, cross-functional collaboration, and regulatory compliance.

The position involves guiding cybersecurity, AI-enabled technologies, and digital health product quality initiatives while coordinating across departments to ensure inspection readiness and compliance.