Senior Quality Manager – Manufacturing

Cephas Consultancy Services Private Limited

United States, Massachusetts

Hybrid · Full-time

Senior Quality Manager – Manufacturing

Location: Littleton, Massachusetts, United States
Job ID: CLI-45721-8
Employment type: Direct hire

We are seeking a Senior Quality Manager – Manufacturing for a manufacturing company in Littleton, Massachusetts. This role owns day-to-day manufacturing quality, leads the Quality Control (QC) Supervisor and Quality Engineering team, and drives quality systems and continuous improvement initiatives.

Key Responsibilities

  • Lead manufacturing-related quality activities across production operations.
  • Oversee in-process inspection, final inspection, product acceptance, and release activities.
  • Manage Quality Engineers, the QC Supervisor, and inspection activities.
  • Own the nonconformance report/material review board (NCR/MRB) process, including investigation, disposition, trending, and timely closure.
  • Drive corrective and preventive action (CAPA) and other corrective actions based on manufacturing quality trends and root-cause analysis.
  • Lead continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction.
  • Apply Lean, Six Sigma, and other process-improvement methodologies.
  • Support new product, equipment, and manufacturing process introductions through quality planning and risk management.
  • Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable international regulations.
  • Support internal and external audits, including FDA and notified-body inspections.
  • Partner with Manufacturing, Engineering, Supply Chain, and Operations to resolve quality issues and improve processes.
  • Support supplier-quality activities related to manufacturing and incoming-material performance.
  • Provide leadership with data-driven reporting on quality performance, risks, trends, and improvement initiatives.
  • Coach and develop the manufacturing Quality team while helping build a strong culture of quality.

Benefits

  • Competitive compensation
  • 10% annual target bonus
  • Health, vision, and dental insurance
  • 401(k) retirement savings with match
  • Life insurance
  • Comprehensive paid leave
  • Flexible working environment