Senior QA Leader — FDA-Regulated Manufacturing

Rockline Industries; Morristown (TN); Presencial; USD 120 000 - 165 000; Tempo integral

Resumo da oferta

Iatric Manufacturing in Morristown, TN seeks a Quality Assurance Manager II to lead QA, QC, and QA Engineering in a regulated manufacturing setting. You will drive quality initiatives, partner with Operations, Engineering, and Global Quality, and support business growth.

The role emphasizes regulatory compliance, product safety, and developing high-performing teams with a focus on audits, CAPA, and risk management.

Qualificações

• Bachelor's degree in Science, Engineering, or related technical field.
• 10+ years of QA leadership experience in an FDA-regulated manufacturing environment.
• Experience leading QA, QC, and QA Engineering functions.
• Strong knowledge of FDA regs (21 CFR Parts 11, 210, 211, 820), cGMP, ISO 13485, CAPA, RCA, and risk management.

Responsabilidades

• Lead Quality Assurance, Quality Control, and Quality Engineering activities.
• Oversee investigations, deviations, nonconforming materials, CAPA, and quality system activities.
• Drive continuous improvement focused on quality, efficiency, and compliance.
• Ensure compliance with FDA regulations, cGMP, and quality management systems.
• Lead internal and external audits and support regulatory inspections.
• Collaborate with customers, suppliers, and cross-functional teams on quality matters.
• Support new product introductions, process validation, and risk management initiatives.
• Develop, mentor, and coach quality professionals; foster accountability and excellence.
• Lead site quality reviews, strategic planning, and management reviews.

Conhecimentos

QA Leadership

FDA Regulations

Team Leadership

CAPA & RCA

Lean Manufacturing

SPC

Process Validation

Formação académica

Bachelor's degree in Science/Engineering

Ferramentas

QMS (Quality Management System)

Statistical software (SPC)

Descrição da oferta de emprego

Iatric Manufacturing in Morristown, TN seeks a Quality Assurance Manager II to lead QA, QC, and QA Engineering in a regulated manufacturing setting. You will drive quality initiatives, partner with Operations, Engineering, and Global Quality, and support business growth.

The role emphasizes regulatory compliance, product safety, and developing high-performing teams with a focus on audits, CAPA, and risk management.