QA/RA Specialist

Position Summary 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. Major Duties & Responsibilities Work closely with production, development, and quality assurance teams to ensure quality protocols are properly implemented and sustained. Develops and maintains 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. Ensures that products comply with all relevant regulations and standards set by global governmental regulatory bodies and industry organizations. Manages 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. Identifypotentialrisksorweaknessesandcoordinatecorrectiveandpreventiveactionstoaddressthem. Provides training or guidance to internal teams Required Education Bachelor’s degree (B.S.) or working equivalent. Required Skills & Experience 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 Joerns Healthcare LLC is an Equal Opportunity Employer, including Disability/Veterans Benefits At Joerns Healthcare LLC, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability. In addition, the company offers a 401K program with a company match, and Flexible Spending Accounts. Our employees also receive Paid Vacation and Holidays. Min USD $75,000.00/Yr. Max USD $85,000.00/Yr. #J-18808-Ljbffr