Senior QA & Compliance Leader – FDA Manufacturing

Iatric-Manufacturing-Solutions-LL; Morristown (TN); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

Iatric Manufacturing in Morristown, TN is seeking a strategic Quality Assurance Manager II to lead our Quality Assurance, Quality Control, and Quality Engineering teams in an FDA-regulated environment. This role is ideal for a quality leader who is passionate about continuous improvement, regulatory compliance, product safety, and developing high-performing teams.

As a member of the site leadership team, you will partner with Operations, Engineering, Product Development, and Global Quality teams

Qualifications

• Bachelor's degree in Science, Engineering, or related technical discipline.
• 10+ years of Quality Assurance leadership in an FDA-regulated setting.
• Experience leading QA, QC, and QE functions.
• Strong knowledge of FDA regs, cGMP, ISO 13485, CAPA, RCA, and risk management.
• Experience with process, cleaning, software, and analytical method validation.
• Exposure to Statistical Process Control and Lean Manufacturing.

Responsabilités

• Lead QA, QC, and QE activities.
• Oversee investigations, deviations, nonconforming materials, CAPA, and QA systems.
• 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 regulatory inspections.
• Collaborate with customers, suppliers, and cross-functional teams.
• Support new product introductions and process validation activities.
• Develop, mentor, and coach quality professionals.
• Lead site quality reviews and management review activities.

Connaissances

FDA regulations

cGMP

ISO 13485

CAPA

Root Cause Analysis

Risk Management

Process Validation

Software Validation

Analytical Validation

Statistical Process Control

Lean Manufacturing

Quality Leadership

Quality Assurance

Formation

Bachelor's degree in Science or Engineering

Description du poste

Iatric Manufacturing in Morristown, TN is seeking a strategic Quality Assurance Manager II to lead our Quality Assurance, Quality Control, and Quality Engineering teams in an FDA-regulated environment. This role is ideal for a quality leader who is passionate about continuous improvement, regulatory compliance, product safety, and developing high-performing teams.

As a member of the site leadership team, you will partner with Operations, Engineering, Product Development, and Global Quality teams