What are the responsibilities and job description for the Quality Systems Process Lead position at Advantage Technical?
Pay Rate: $64.50/hour
Hybrid position - 3 days in Marlborough
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.
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.
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.
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
Salary : $65