Quality Assurance 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

About Us

Founded in 2000 locally owned and operated, RbM Services is a growing turn‑key design, manufacture, and service solution provider for medical devices in Tennessee’s Technology Corridor. With over 100 years of combined experience in the medical device industry, our management staff has extensive experience in intellectual property development, contract design, product development, field service support, and product support of medical devices and laboratory instrumentation. Our team is passionate and even obsessed with providing solutions that deliver cutting‑edge technology that improves patient experiences and outcomes. Our passion lies in the pursuit of perfection. We value our employee family and foster opportunities for us to engage in meaningful connections and we reward employees who exceed expectations.

Quality Assurance Specialist Job Description

The Quality & Regulatory Affairs Specialist will support the Q&RA Management team in ensuring compliance to regulations and standards and meeting customer requirements.

Responsibilities

• Assist Q&RA 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

Required Qualifications

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

Benefits

As a full‑time team employee, you are eligible for all RbM Services benefits, including medical, dental, vision, long‑term, short‑term disability, 401k, PTO, 10 paid holidays, etc.

All your information will be kept confidential according to the EEO guidelines.