QA/RA Specialist

About the role

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.

Responsibilities

• Develops and maintains quality assurance documentation, including SOPs, protocols, checklists, and reporting templates.
• Facilitates 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.
• Works 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.
• Stays abreast of evolving regulations and often serves as the primary point of contact between the company and regulatory agencies during product approvals, audits, and inspections.
• Identifies potential risks or weaknesses and coordinates corrective and preventive actions to address them.
• Provides training or guidance to internal teams.

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).

Qualifications

• Effective communication skills.
• Team player.
• Ability to maintain effective working relationships.

Skills

• Knowledge of regulatory requirements and standards.
• Experience with quality management systems (QMS).
• Strong organizational and attention to detail skills.
• Excellent problem-solving and critical thinking abilities.

Benefits

Joerns Healthcare LLC offers 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. USD $75,000.00/Yr. USD $85,000.00/Yr.

Pay

USD $75,000.00/Yr. USD $85,000.00/Yr.

Schedule

N/A