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. 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. Apply Now If you're a quality systems professional with a strong regulatory background and a passion for process improvement, we want to hear from you. Apply today to bring your expertise to a high-impact temporary role and help drive quality excellence. 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. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. 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. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.