Quality Manager

Premier Global Links; Littleton (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

Life insurance

Paid leave

Flexible working

Job summary

Premier Global Links LLC in Littleton, Massachusetts seeks an experienced Operations Quality Manager to lead manufacturing quality operations, quality engineering, inspection activities, and quality systems.

You will manage Quality Engineers and QC staff, drive CAPA and NCR/MRB processes, and guide continuous improvement initiatives focused on quality, yield, and process efficiency. Strong knowledge of FDA QMSR and ISO 13485 is required.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 8+ years of progressive quality experience in medical device, aerospace, defense, or IVD manufacturing.
• 3+ years of experience managing Quality Engineers and/or QC teams.
• Medical device manufacturing experience required; ISO 13485 knowledge.
• Strong knowledge of ISO 13485 and risk-based quality principles.

Responsibilities

• Lead manufacturing quality activities across production operations.
• Oversee in-process inspection, final inspection, product acceptance, and release activities.
• Manage Quality Engineers, the QC Supervisor, and manufacturing inspection functions.
• Own the NCR/MRB process, including investigation, disposition, trending, and closure.
• Lead CAPA and corrective action activities using data analysis and root cause investigation.
• Drive continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction.
• Apply Lean, Six Sigma, and other process improvement methodologies as appropriate.
• Support new product introductions, equipment installations, and process changes through quality planning and risk assessment.
• Ensure compliance with FDA QMSR, ISO 13485, and applicable regulatory requirements.
• Assist audits, including FDA and notified body inspections.
• Partner with Manufacturing, Engineering, Supply Chain, and Operations to resolve quality issues.

Skills

Quality management

Quality engineering

NCR/MRB

CAPA

Lean Six Sigma

Root cause analysis

Data analysis

Leadership

Communication

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

About the Role

Premier Global Links LLC is seeking an experienced Operations Quality Manager to lead manufacturing quality operations for a company in Littleton, Massachusetts.

This role is responsible for day-to-day manufacturing quality, quality engineering, inspection activities, quality systems, corrective actions, and continuous improvement. The successful candidate will lead Quality Engineers and QC operations while partnering closely with Manufacturing, Engineering, Supply Chain, and Operations teams.

Key Responsibilities

• Lead manufacturing quality activities across production operations.
• Oversee in-process inspection, final inspection, product acceptance, and release activities.
• Manage Quality Engineers, the QC Supervisor, and manufacturing inspection functions.
• Own the NCR/MRB process, including investigation, disposition, trending, and timely closure.
• Lead CAPA and corrective action activities using data analysis and root cause investigation.
• Drive continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction.
• Apply Lean, Six Sigma, and other process improvement methodologies as appropriate.
• Support new product introductions, equipment installations, and manufacturing process changes through quality planning and risk assessment.
• Ensure compliance with FDA QMSR, ISO 13485, and applicable regulatory requirements.
• 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 reports on quality performance, risks, trends, and improvement initiatives.
• Coach and develop the manufacturing Quality team and promote a strong quality culture.

Required Qualifications

• Bachelor's degree in Engineering, including Mechanical Engineering, Electrical Engineering, or a related discipline, or equivalent education and experience.
• 8+ years of progressive Quality experience in medical device, aerospace, defense, or IVD manufacturing.
• Prior medical device manufacturing experience is required.
• 3+ years of experience managing Quality Engineers and/or QC teams.
• Experience leading Manufacturing Quality activities, NCR/MRB processes, and shop-floor quality execution.
• Strong knowledge of ISO 13485 and risk-based quality principles.
• Strong analytical, problem-solving, leadership, and communication skills.
• Ability to work collaboratively across manufacturing and technical functions.
• Willingness and ability to travel approximately 5–10% to support vendors, customer sites, troubleshooting, and system testing.

Compensation & Benefits

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

Premier Global Links LLC is an Equal Opportunity Employer. Qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other status protected by applicable law.