QA/RA Coordinator

Joerns Healthcare•Charlotte, NC

1d•$60,000 - $75,000

About The Position

Under the general direction of the Global Quality and Regulatory Affairs Director, 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.

Requirements

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

Responsibilities

Work closely with production, development, and quality assurance teams to ensure quality protocols are properly implemened and sustained.
Assist and/or develop and maintain quality assurance documentation, including SOPs, protocols, checklists, and reporting templates.
Facilitating audits (Rental ETC’s): ensure the company is audit-ready and compliant with local or international quality certifications, specifically JACHO and Medicare/Medicaid Standards.
Assist with ensuring that products comply with all relevant regulations and standards set by global governmental regulatory bodies and industry organizations.
Assist with/help 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.
Work closely 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.
Assist with and/or provide training or guidance to internal teams