Quality Operations Manager

SnapX.ai; Littleton (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Annual performance bonus

401k with match

Paid leave

Flexible working environment

Job summary

SnapX.ai is seeking an experienced Operations Quality Manager to lead day-to-day manufacturing quality, oversee inspection activities, and drive continuous improvement initiatives in Littleton, MA. The role manages the QC Supervisor and Quality Engineering team, ensuring compliance with FDA and ISO standards while promoting a culture of quality.

The ideal candidate has 7+ years in manufacturing quality, 3+ years in leadership, and deep knowledge of SPC, FMEA, CAPA, and root cause analysis.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related field.
• 7+ years of manufacturing quality experience.
• 3+ years in supervisory or leadership roles.
• Strong knowledge of quality tools (SPC, FMEA, CAPA, root cause analysis).
• Experience with ISO 13485, FDA QMSR, and regulated manufacturing environments.
• Lean/Six Sigma experience preferred.

Responsibilities

• Lead all manufacturing quality activities across production operations.
• Oversee in-process inspection, final inspection, product acceptance, and release.
• Manage Quality Engineers, QC Supervisor, and inspection teams.
• Own the NCR/MRB process including investigation, disposition, trending, and closure.
• Drive CAPA and corrective actions based on root cause analysis.
• Lead continuous improvement initiatives focused on yield, efficiency, and risk reduction.
• Apply Lean, Six Sigma, and process improvement methodologies.
• Support new product, equipment, and process introductions through quality planning.
• Ensure compliance with FDA QMSR, ISO 13485, and international regulations.
• Support internal/external audits including FDA and notified body inspections.
• Partner cross-functionally with Manufacturing, Engineering, Supply Chain, and Operations.
• Provide leadership with data-driven reporting on quality performance and risks.
• Coach and develop the manufacturing Quality team.

Skills

Quality leadership

FMEA

CAPA

Root cause analysis

SPC

Lean/Six Sigma

Regulatory knowledge

Education

Bachelor's degree in Engineering, Quality, Manufacturing, or related field

Job description

Company Description SnapX.ai is a next-generation freelance recruiting portal that combines AI agents with human expertise to deliver highly qualified talent for diverse hiring needs. Organizations can post a job and quickly receive applicants sourced through a network of 1,000+ freelance recruiters. The platform is designed to streamline recruitment workflows, improve candidate quality, and reduce time-to-hire. SnapX.ai focuses on creating efficient, technology-enabled hiring experiences for both clients and talent professionals.

Operations Quality Manager - Manufacturing | Littleton, MA

We are seeking an experienced Operations Quality Manager to lead day-to-day manufacturing quality, oversee inspection activities, and drive continuous improvement initiatives. This is a high-visibility leadership role managing the QC Supervisor and Quality Engineering team, ensuring compliance with FDA and ISO standards while building a strong culture of quality.

Responsibilities

• Lead all manufacturing quality activities across production operations.
• Oversee in-process inspection, final inspection, product acceptance, and release.
• Manage Quality Engineers, QC Supervisor, and inspection teams.
• Own the NCR/MRB process including investigation, disposition, trending, and closure.
• Drive CAPA and corrective actions based on root cause analysis.
• Lead continuous improvement initiatives focused on yield, efficiency, and risk reduction.
• Apply Lean, Six Sigma, and process improvement methodologies.
• Support new product, equipment, and process introductions through quality planning.
• Ensure compliance with FDA QMSR, ISO 13485, and international regulations.
• Support internal/external audits including FDA and notified body inspections.
• Partner cross-functionally with Manufacturing, Engineering, Supply Chain, and Operations.
• Provide leadership with data-driven reporting on quality performance and risks.
• Coach and develop the manufacturing Quality team.

Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, or related field.
• 7+ years of manufacturing quality experience.
• 3+ years in supervisory or leadership roles.
• Strong knowledge of quality tools (SPC, FMEA, CAPA, root cause analysis).
• Experience with ISO 13485, FDA QMSR, and regulated manufacturing environments.
• Lean/Six Sigma experience preferred.
• Excellent analytical, organizational, and leadership skills.

Benefits

• Competitive compensation package.
• Annual performance bonus.
• Health, vision, and dental insurance.
• 401k retirement savings with match.
• Life insurance and comprehensive paid leave.
• Flexible working environment.