Overview
Senior Quality Specialist Jobs in Nashville, TN at ACE Partners
Title: Senior Quality Specialist
Company: ACE Partners
Location: Nashville, TN
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
