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Quality System Specialist

Job

Matlen Silver

Cary, IL (In Person)

Full-Time

Posted 1 week ago (Updated 5 days ago) • Actively hiring

Expires 7/21/2026

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Job Description

Only
W2 , NO C2C.
Position Overview:
We are seeking a highly skilled Regulatory & Quality Systems Specialist to support regulatory compliance and quality initiatives for medical devices, both in the U.S. and internationally. The ideal candidate will have in-depth knowledge of
U.S. FDA
regulations, EU MDR , and MDSAP , with hands-on experience in 510(k) submissions and EU Class II devices . This is a contract role based on-site in Cary, IL , offering an exciting opportunity to contribute to high-impact regulatory and quality operations.
Key Responsibilities:
Ensure compliance with U.S. and international medical device regulations , including MDSAP Provide regulatory support for 510(k) submissions and EU Class II device registrations Maintain and improve Quality Management Systems (QMS) across key areas, including: Measurement, Analysis, and Improvement Adverse Event and Advisory Reporting Purchasing and Supplier Controls Design & Development Production and Service Controls  Lead or support internal and external audits  Develop and maintain technical documentation , including procedures and SOPs  Collaborate cross-functionally with R D, Operations, and Regulatory Affairs teams  Monitor and assess compliance risks , recommending and implementing corrective actions  Analyze data to identify trends and define actionable improvements  Communicate effectively with stakeholders across all levels of the organization  Support project planning and execution across multiple concurrent tasks  Act with a customer- and stakeholder-focused mindset
Required Qualifications:
Bachelor's degree required , preferably in Engineering, Life Sciences, Regulatory Affairs, or a related field Strong knowledge of
FDA, EU MDR, MDSAP
, and other international medical device regulations Direct experience with
U.S. 510
(k) submissions and EU Class II device compliance In-depth understanding of Quality Systems and relevant standards (e.g., ISO 13485) Proven audit experience (internal, supplier, and regulatory) Excellent project management , analytical, and decision-making skills Strong written and verbal communication and interpersonal skills Ability to manage multiple priorities in a fast-paced environment Experience in technical writing and procedure development Proficiency with Microsoft Office and relevant quality/regulatory software Ability to travel occasionally, as required