Quality Assurance & Regulatory Affairs Specialist

Rbm-Services,-LLC-; Knoxville (TN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k

PTO

10 paid holidays

Job summary

RbM Services in Knoxville, TN is seeking a Quality Assurance Specialist to support the QRA Management team in maintaining compliance with regulations and customer requirements. The role emphasizes developing and revising QMS documentation and performing internal audits to ensure ongoing quality.

This full-time position offers comprehensive benefits and opportunities to contribute to medical device quality systems.

Qualifications

• 2–5 years’ experience in Quality and Regulatory roles (preferred Medical Device manufacturing).
• Experience with ISO 9001 or 13485.
• Experience generating and revising QMS documentation.
• Manage multiple assignments concurrently.
• Excellent written and verbal communication skills.

Responsibilities

• Assist QRA Management with development and revision of quality process documentation (SOPs, work instructions, forms & templates).
• Documenting and following up on events (Nonconforming material, CAPA, audit findings, etc.).
• Internal Auditing of the QMS.
• Quarterly Trending of Data.
• Training activities

Skills

Quality & Regulatory

QMS Documentation

Stakeholder Communication

Regulatory Standards

Job description

RbM Services in Knoxville, TN is seeking a Quality Assurance Specialist to support the QRA Management team in maintaining compliance with regulations and customer requirements. The role emphasizes developing and revising QMS documentation and performing internal audits to ensure ongoing quality.

This full-time position offers comprehensive benefits and opportunities to contribute to medical device quality systems.