Quality Specialist

We are seeking an experienced Quality Specialist to join a growing Regulatory Affairs & Quality Assurance team supporting medical device, pharmaceutical, and combination product sterilization operations.This role is ideal for a quality professional who thrives in a GMP-regulated environment and is passionate about driving compliance, process improvements, and quality excellence.Key ResponsibilitiesManage the Change Control process, including ECO documentation, SOP creation, revisions, and approvalsMaintain and administer the company-wide training programCertify and recertify employees on quality policies and proceduresManage the Approved Supplier List and supplier qualification activitiesOversee incoming inspection processesEnsure compliance with FDA regulations and industry standards, including QMSR, 21 CFR Parts 210/211, ISO 13485, and ISO 14971Collaborate with Operations, Engineering, Validation, R&D, and Quality teams to support project execution and regulatory complianceSupport operational excellence initiatives while maintaining quality and performance objectivesQualificationsRequired:Bachelor's degree in Engineering, Science, or a related field (or equivalent experience)3-7 years of Quality experience in a GMP-regulated industryCertified Quality Engineer (CQE) or equivalent qualificationStrong knowledge of cGMP, QMSR, ISO 13485, and ISO 14971Excellent communication, organizational, and project management skillsAbility to manage multiple priorities in a fast-paced environmentStrong analytical, problem-solving, and decision-making abilitiesAuthorized to work in the United StatesPreferred:Experience in contract sterilization, medical device, pharmaceutical, or combination product environmentsWhat Success Looks LikeThe ideal candidate is a proactive quality professional who takes ownership, drives projects to completion, and builds strong cross-functional relationships while ensuring the highest standards of compliance and quality.If you're looking for an opportunity to make a meaningful impact in a highly regulated and growing industry, we'd love to hear from you.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.To find out more about Real, please visit