Quality Assurance Specialist

Quality & Regulatory Affairs Specialist

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