Quality Systems Process Lead

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

Now Hiring: Quality Systems Process Lead (QMS)

Location: Marlborough, MA
Pay Rate: $64.50/hour
Hybrid position - 3 days in Marlborough

Join a leading medical device manufacturing environment and play a key role in shaping the future of quality systems, supplier processes, cybersecurity, AI technologies, and regulatory compliance. This is an excellent opportunity for an experienced quality professional who enjoys driving process improvements, leading cross-functional initiatives, and making a lasting impact on global quality operations.

Education Requirements

Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related field preferred.

Experience Requirements

• 5+ years of experience in Quality Systems, Supplier Quality, Regulatory Compliance, or related quality functions within a regulated industry
• Experience in medical device, healthcare, or other regulated manufacturing environments preferred
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 62304, IMDRF, and cybersecurity-related quality requirements
• Experience leading process improvement initiatives and collaborating across multiple departments
• Proven leadership skills with the ability to take initiative and influence stakeholders

Job Duties

• Lead quality system process improvements related to supplier controls and sourced materials
• Support initiatives involving cybersecurity, AI-enabled technologies, software, and digital health products
• Develop and maintain quality procedures, work instructions, templates, and documentation
• Coordinate cross-functional teams to implement process enhancements and compliance initiatives
• Evaluate supplier lifecycle management, risk management, change controls, and qualification processes
• Partner with business leaders to strengthen quality and regulatory compliance across the organization
• Drive projects from planning through implementation while ensuring inspection readiness

Physical Capabilities

• Ability to work in an office and collaborative business environment
• Ability to sit, stand, and operate a computer for extended periods

Employee Benefits

• Medical, Dental, Vision, and Pet Insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks Program
• Health Savings Account (HSA)
• AD&D Insurance

Why You'll Love This Role

This position offers the opportunity to work on cutting-edge quality initiatives involving cybersecurity, artificial intelligence, and advanced medical technologies while partnering with teams across the business to improve processes that support innovative healthcare products.