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.

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.

• Manage the Change Control process, including ECO documentation, SOP creation, revisions, and approvals
• Maintain and administer the company-wide training program
• Certify and recertify employees on quality policies and procedures
• Manage the Approved Supplier List and supplier qualification activities
• Oversee incoming inspection processes
• Ensure compliance with FDA regulations and industry standards, including QMSR, 21 CFR Parts 210/211, ISO 13485, and ISO 14971
• Collaborate with Operations, Engineering, Validation, R&D, and Quality teams to support project execution and regulatory compliance
• Support operational excellence initiatives while maintaining quality and performance objectives

Required:

• Bachelor's degree in Engineering, Science, or a related field (or equivalent experience)
• 3-7 years of Quality experience in a GMP-regulated industry
• Certified Quality Engineer (CQE) or equivalent qualification
• Strong knowledge of cGMP, QMSR, ISO 13485, and ISO 14971
• Excellent communication, organizational, and project management skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong analytical, problem-solving, and decision-making abilities
• Authorized to work in the United States

• Experience in contract sterilization, medical device, pharmaceutical, or combination product environments

The 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.

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.