Quality Manager
Core
Establish, manage, and maintain plant quality systems to ensure product safety and quality, including auditing departments, managing continuous improvement, and handling non-conforming product disposition.
Role type
Quality Manager (Manufacturing)
Builds
Finished products compliant with customer specifications and regulatory standards (ISO 15378, GFSI, cGMP, FDA 21 CFR).
Domain
Manufacturing / Quality Assurance / Food & Packaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (Quality systems, SPC, audit conformance)
Required skills
Quality systems management, systems auditing, statistical sampling plans (ANSI/ASQ/MilStd), Statistical Process Control (SPC), root cause analysis, project management, technical writing, cGMP knowledge, FDA regulations knowledge (21 CFR 110, 210, 211), leadership, budget management.
Preferred skills
Molding & decorating processes knowledge, ASQ certifications, team facilitation for continuous improvement.
Technologies
SPC software, statistical tools, computer software for quality systems.
Responsibilities
Develop and implement quality systems; manage internal, customer, and system audits (ISO 15378, GFSI); facilitate root cause investigations and corrective actions; provide disposition for non-conforming product; coordinate SPC system implementation and training; manage quality budgets; support customer quality issues and complaints.
Seniority
Mid-Senior, hands-on IC with management oversight of quality staff.
