Senior Quality Manager - Manufacturing

JVMH Infotech; Massachusetts; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

10% annual bonus

Health, vision and dental insurance

Life insurance

Comprehensive paid leave

Flexible working environment

Job summary

We are seeking an Operations Quality Manager for a manufacturing company in Littleton, MA. This role will own day-to-day manufacturing quality, lead the QC Supervisor and Quality Engineering team, and drive quality systems and continuous improvement initiatives.

The candidate will oversee all manufacturing-related quality activities, manage a team of Quality Engineers and inspection staff, and ensure compliance with FDA QMSR and ISO 13485.

Qualifications

• 8 years of experience in manufacturing quality.
• Experience in medical devices manufacturing and quality systems.
• Knowledge of FDA QMSR and ISO 13485.
• Experience leading Quality Engineers and QC Supervisors.
• Experience with NCR/MRB, CAPA and trending.

Responsibilities

• Lead all manufacturing-related quality activities across production operations.
• Oversee in-process and final inspection, product acceptance and release.
• Manage Quality Engineers, the QC Supervisor, and inspection activities.
• Own the NCR/MRB process including investigation and closure.
• Drive CAPA and root cause analysis for quality trends.
• Lead continuous improvement focusing on quality, yield, efficiency, and risk reduction.
• Ensure FDA QMSR and ISO 13485 compliance and support audits.
• Collaborate with Manufacturing, Engineering, Supply Chain to resolve quality issues.

Skills

Quality management

Lean

Six Sigma

CAPA

Data-driven reporting

Education

High school diploma

Job description

Senior Quality Manager Manufacturing

Experience level: Mid-senior

Experience required: 8 Years

Education level: High school or equivalent

Job function: Engineering

Industry: Medical Devices

Total position: 1

Relocation assistance: No

We are seeking an Operations Quality Manager for a manufacturing company in Littleton, MA. This role will own day-to-day manufacturing quality, lead the QC Supervisor and Quality Engineering team, and drive quality systems and continuous improvement initiatives.

Key Responsibilities

• Lead all 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 NCR/MRB process, including investigation, disposition, trending, and timely closure.


• Drive CAPA and 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 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


• Life insurance


• Comprehensive paid leave


• Flexible working environment