Quality Systems Process Lead

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.

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

• 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

• 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

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

• 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

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.