QA​/RA Specialist

Role Overview

The QA/RA Coordinator ensures products and processes meet quality standards (QA) and regulatory requirements (RA) by managing compliance documentation, conducting audits, and overseeing quality management systems.

• Work closely with production, development, and quality assurance teams to ensure quality protocols are properly implemented and sustained.
• Develop and maintain quality assurance documentation, including SOPs, protocols, checklists, and reporting templates.
• Facilitate audits (Rental ETC’s) to ensure the company is audit-ready and compliant with local or international quality certifications, specifically JACHO and Medicare/Medicaid Standards.
• Ensure that products comply with all relevant regulations and standards set by global governmental regulatory bodies and industry organizations.
• Manage the preparation, submission, and maintenance of regulatory documentation, ensuring that every aspect of a product—from its formulation to its packaging—adheres to stringent regulatory guidelines.
• Collaborate with cross‑functional teams—including research and development, quality assurance, marketing, and legal departments—to gather necessary information and ensure compliance throughout the product development process.
• Stay abreast of evolving regulations and often serve as the primary point of contact between the company and regulatory agencies during product approvals, audits, and inspections.
• Identify potential risks or weaknesses and coordinate corrective and preventive actions to address them.
• Provide training or guidance to internal teams.

• Bachelor’s degree (B.S.) or equivalent professional experience.
• 5+ years of audit experience, document control (Arena), QMS and/or regulatory experience.
• Proficient in Microsoft Office Suite (Word, Excel at a minimum).
• Ability to maintain effective working relationships and support an atmosphere of teamwork.

Joerns Healthcare LLC is an Equal Opportunity Employer, including Disability/Veterans

USD $75,000.00 per year. USD $85,000.00 per year.