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Quality Systems Specialist
Job Description
We are looking to add talented Quality Systems Specialists to our database for future opportunities in regulatory compliance and quality management. This role focuses on implementing, maintaining, and improving quality management systems across regulated environments, with scope to support organizations in achieving and sustaining compliance with industry standards and regulatory frameworks. Please note the content of this advert does not represent a live vacancy. About the opportunity This is an opportunity to register your interest in future Quality Systems Specialist positions within regulatory compliance and quality assurance functions. Roles of this type typically sit within organizations that prioritize quality governance, risk management, and regulatory adherence. The work could involve partnering across engineering, operations, and compliance teams to design, document, and audit quality systems under frameworks such as
ISO 9001, ISO
13485, or ISO 27001, with scope to support the organization's quality objectives and regulatory standing. Typical role overview
Location:
Chicago, Illinois, USA Type:
Permanent
•
Full-time Salary:
$105,000 - $170,000 per year, dependent on experience
Domain:
Quality management systems
• regulatory compliance
• audit and risk management What you would do Typical responsibilities could include: Developing, implementing, and maintaining quality management system documentation and procedures Conducting internal and external quality audits to assess compliance with ISO standards and regulatory requirements Identifying, documenting, and driving closure of non-conformances and observations Supporting risk assessments and managing corrective and preventive action (CAPA) processes Collaborating with cross-functional teams to ensure quality systems are embedded across operations Maintaining audit schedules, documentation, and quality records Assisting with regulatory submissions and responding to regulatory inquiries Supporting management reviews and continuous improvement initiatives What you could bring Most roles of this type require the following: Must-have 2-5 years of experience in quality systems, quality assurance, or compliance roles Working knowledge of quality management frameworks such as
ISO 9001, ISO
13485, or equivalent regulated industry standards Experience conducting internal audits and supporting external audit processes Familiarity with risk assessment methodologies and CAPA management Strong documentation, attention to detail, and organizational skills Authorization to work in the United States Nice-to-have Certification as a Certified Compliance Professional (CCP) or
ISO 27001
Lead Auditor Bachelor's degree in Engineering, Quality Management, or related field Experience in medical device, pharmaceutical, or life sciences environments Knowledge of FDA regulations, EU MDR, or other regional compliance frameworks What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Opportunity to support organizations in achieving and maintaining regulatory compliance Exposure to quality systems across multiple functional areas and regulated environments Potential for progression toward senior quality or compliance leadership roles Professional development in regulatory frameworks, audit methodologies, and quality standards Structured learning opportunities and mentorship in quality management disciplines Competitive benefits package including medical, dental, and vision coverage, paid time off, 401(k) matching, and flexible compensation options About Specialist Staffing Group Specialist Staffing Group partners with organizations across regulated industries to build teams that drive quality, compliance, and operational excellence. We work with leading employers in life sciences, medical devices, pharmaceuticals, and technology to identify talent that can support their regulatory and quality objectives. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.
Benefits
- Paid Time Off (PTO)
- 401(k) Plans
- Professional Development
- Health Insurance