Quality Systems Process Lead

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

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.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors.