Essential Functions:

• Develop, implement, and maintain quality procedures for packaging and labeling.
• Conduct regular inspections and audits of packaging and labeling processes.
• Ensure compliance with industry standards, regulatory requirements, and company policies.

Process Improvement:

• Identify and analyze packaging and labeling process inefficiencies and implement corrective actions.
• Lead continuous improvement initiatives to enhance product quality and operational efficiency.
• Collaborate with production teams to resolve quality issues and implement best practices.

Documentation & Reporting:

• Maintain comprehensive documentation of quality processes, inspections, and audits.
• Prepare detailed reports on quality metrics, trends, and corrective actions.
• Ensure all packaging and labeling documentation complies with regulatory standards.

Regulatory Compliance:

• Stay updated on current regulations and standards related to packaging and labeling in the industry.
• Ensure that all packaging and labeling activities comply with relevant regulations such as FDA, ISO, and other applicable standards.

Training & Development:

• Train and mentor production staff on quality standards and procedures.
• Develop training materials and conduct regular training sessions on packaging and labeling quality.

Cross-Functional Collaboration:

• Work closely with R&D, manufacturing, and regulatory teams to support new product development and launches.
• Participate in design reviews and provide input on the packaging and labeling requirements.

Requirements:

• Bachelor’s degree in quality, mechanical or industrial engineering, Quality Management, or related field.
• Minimum of 3-5 years of experience in quality engineering with a focus on packaging and labeling.
• Strong knowledge of quality control principles, methodologies, and tools.
• Familiarity with regulatory standards such as FDA, ISO, and GMP.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team environment and manage multiple projects simultaneously.
• Proficiency in quality management software and Microsoft Office Suite.
• Six Sigma or Lean Manufacturing certification.
• Experience in the medical device or pharmaceutical industry.
• Knowledge of statistical analysis software (e.g., Minitab).