Senior Quality Specialist Position Available In Davidson, Tennessee

Location:

Nashville, Tennessee (On-site) About the

Role:

In this role, you’ll play a key part in ensuring the quality, safety, and compliance of our manufacturing operations. You will support quality control, manage the Quality Management System (QMS), and take ownership of document control processes.

Key Responsibilities:

Oversee and maintain the Quality Management System (QMS) in accordance with ISO 13485 and

FDA 21 CFR

Part 820 Support manufacturing operations through quality inspections , audits, and data analysis Manage Document Control processes, including SOPs, forms, and records lifecycle Lead and support CAPA, NCR, and complaint investigations Collaborate cross-functionally with Engineering, Production, and Regulatory teams to ensure compliance and readiness Assist in internal and external audits (FDA, ISO, customer) Participate in supplier quality assurance, including evaluations and performance monitoring Support ongoing continuous improvement initiatives across the quality system

Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or related field 4+ years of experience in Quality Assurance within the medical device industry Strong knowledge of

ISO 13485 , FDA QSR

, and QMS best practices Hands-on experience with document control systems and quality records management Familiarity with quality tools (CAPA, Root Cause Analysis, Risk Management) Excellent communication, organization, and problem-solving skills

Preferred:

Experience in a manufacturing setting Proficiency in electronic QMS/document control systems (e.g., MasterControl, Greenlight Guru) Auditor certification (CQA, ISO 13485 Lead Auditor) a plus