In-process Quality Assurance Specialist

Key Responsibilities

1. Quality Strategy & Leadership

• Develop and implement manufacturing quality assurance strategies and improvement plans.
• Establish manufacturing process quality standards, specifications, and controls.
• Utilize data-driven decision-making to enhance quality performance.
• Provide quality performance reporting to management and stakeholders.
• Mentor and support quality professionals where applicable.
• Deliver quality awareness training and coaching to manufacturing personnel.

2. Customer Quality Focus

• Support fulfillment of customer-specific quality requirements.
• Analyze customer complaints, feedback, and quality concerns.
• Participate in cross-functional initiatives aimed at improving customer satisfaction.
• Translate customer expectations into manufacturing process improvements.

3. Quality Management System (QMS)

• Develop and maintain SOPs, work instructions, and process controls.
• Conduct process audits and compliance assessments.
• Ensure adherence to quality standards, procedures, and regulatory requirements.
• Train manufacturing teams on quality management practices and risk mitigation methods.

4. Manufacturing Quality Assurance

• Conduct Process Failure Mode and Effects Analysis (PFMEA).
• Identify manufacturing and assembly process risks.
• Develop and implement risk mitigation plans.
• Collaborate with cross-functional teams to eliminate potential quality failures.
• Monitor effectiveness of risk controls and preventive actions.
• Maintain and update risk assessments throughout the product lifecycle.
• Manage change control activities related to:
  • Product features
  • Manufacturing processes
  • Materials
  • Suppliers
  • Design modifications

5. Quality Control

• Implement quality control plans and inspection requirements.
• Conduct process audits, inspections, and verification activities.
• Analyze test results, measurements, and statistical quality data.
• Identify trends and improvement opportunities through data analysis.
• Recommend and implement corrective actions to improve quality performance.

6. Process Performance Management

• Monitor key process performance indicators.
• Analyze manufacturing performance data and trends.
• Support implementation of Statistical Process Control (SPC) techniques.
• Maintain process performance documentation.
• Drive corrective and preventive actions to improve process capability and efficiency.
• Train operators and manufacturing teams on performance monitoring methods.

7. Non-Conformance Management

• Investigate process and product non-conformities.
• Lead root cause analyses using structured problem-solving methodologies such as:
  • 8D
  • 5 Why Analysis
  • Fishbone Diagram
  • Statistical Analysis Tools
• Implement and verify effectiveness of corrective and preventive actions (CAPA).

8. Continuous Improvement

• Lead and support continuous improvement initiatives across manufacturing operations.
• Identify opportunities to improve:
  • Process capability
  • Product quality
  • Productivity
  • Cost efficiency
  • Operational performance
• Participate in Lean and Six Sigma projects.
• Facilitate waste reduction and process optimization activities.
• Prioritize and execute improvement projects based on business impact.

Authority & Accountability

The position is accountable for:

• Quality risk identification and mitigation.
• PFMEA development and maintenance.
• Manufacturing quality assurance activities.
• Process audit execution.
• Quality performance monitoring.
• Continuous improvement project execution.
• Supporting customer quality requirements and compliance.