QA/RA Specialist

About the role

The QA/RA Specialist 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

• 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.
• Ensures 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.
• 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.
• 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 and interpersonal skills.
• Strong organizational and time management skills.
• Ability to maintain effective working relationships and present and support an atmosphere of teamwork.

Skills

• Quality Assurance and Regulatory Compliance.
• Audit Experience.
• Document Control (Arena).
• Quality Management Systems (QMS).
• Microsoft Office Suite (Word, Excel).

Benefits

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

Nightly Shifts

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