Quality Assurance Specialist

Quality & Regulatory Affairs Specialist

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.

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
• Other Duties as assigned

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
• Microsoft Office Suite Proficient
• Manage multiple assignments simultaneously
• Excellent written and verbal communication skills

Additional Information:

• 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