Quality Manager

Quality Manager

The Quality Manager is responsible for leading and maintaining the site Quality Management System (QMS) in compliance with ISO 9001:2015, ensuring product quality, regulatory compliance, and continuous improvement across manufacturing operations. This role drives data-driven decision-making, oversees quality assurance and control activities, manages supplier quality, and leads cross-functional teams in resolving quality issues through structured problem-solving methodologies.

Job Responsibilities:

• Quality Management System (QMS) & Compliance
  • Maintain and improve the site Quality Management System in alignment with ISO 9001:2015 standards.
  • Ensure compliance with documented information requirements, including document control, records retention, and revision management.
  • Lead internal and external audit preparation, execution, and follow-up, ensuring timely closure of findings.
  • Develop, review, and approve SOPs, work instructions, and quality procedures.
• Data Analysis & Continuous Improvement
  • Perform Pareto analysis on defects, nonconformances, and yield data to identify high-impact improvement opportunities.
  • Analyze quality metrics and trends using statistical tools to support decision-making.
  • Present quality performance, risks, and improvement initiatives to leadership during reviews.
  • Drive continuous improvement efforts using structured methodologies.
• Root Cause Analysis & CAPA Management
  • Lead and facilitate root cause investigations using methodologies such as 5 Whys, Fishbone diagrams, and fault tree analysis.
  • Develop and implement Corrective and Preventive Actions (CAPA) for internal and external quality issues.
  • Verify effectiveness of corrective actions and ensure sustained resolution.
  • Prevent recurrence of nonconformances through systemic improvements.
• Nonconformance & Customer Complaint Management
  • Oversee the control and disposition of nonconforming materials.
  • Manage investigation and resolution of customer complaints, including communication and reporting.
  • Coordinate cross-functional teams to address quality issues and implement corrective actions.
• Supplier Quality Management
  • Lead supplier quality initiatives including qualification, performance monitoring, and corrective actions.
  • Collaborate with suppliers and purchasing to improve incoming material quality.
  • Oversee incoming inspection and testing to ensure compliance with specifications.
• Cross-Functional Collaboration
  • Partner with engineering, operations, R&D, and supply chain to resolve quality issues and improve processes.
  • Support new product introductions, process changes, and validation activities.
  • Facilitate problem-solving discussions and quality improvement initiatives across departments.
• Team Leadership & Development
  • Supervise, mentor, and develop quality team members.
  • Provide training and guidance on quality standards, inspection methods, and problem-solving techniques.
  • Promote a culture of continuous improvement, accountability, and engagement.
• Audit & Risk Management
  • Ensure ongoing readiness for customer, regulatory, and certification audits.
  • Identify quality risks and implement mitigation strategies aligned with ISO risk-based thinking.
  • Monitor key performance indicators and implement proactive actions to reduce defects and variation.

Education,

Skills & Experience:

• Bachelor's degree in a technical or scientific discipline (preferred).
• Minimum 5–8 years of experience in Quality Assurance/Quality Control in a manufacturing environment.
• Experience managing audits and Quality Management Systems.
• Technical Skills
  • Strong knowledge of ISO 9001:2015 standards and implementation.
  • Experience with root cause analysis, CAPA, and continuous improvement methodologies.
  • Proficiency in data analysis and statistical tools (Excel, Minitab).
  • Knowledge of chemical or manufacturing processes (preferred).
• Core Competencies
  • Data-driven decision making and analytical thinking
  • Leadership and team development
  • Strong communication and cross-functional collaboration
  • Problem-solving and process improvement
  • Attention to detail and compliance focus
• Working Conditions
  • Combination of office and manufacturing floor environment
  • May require participation in audits, meetings, and occasional travel
  • Interaction with cross-functional teams and global stakeholders
• Key Performance Indicators (KPIs)
  • Reduction in defects and nonconformances
  • Effectiveness of corrective actions (CAPA closure and recurrence rate)
  • Audit performance and compliance status
  • Supplier quality performance
  • On-time resolution of customer complaints

Comprehensive Benefits Include:

• Health, Dental and Vision
• Flexible vacation policy
• 401K
• Life Insurance