Quality Assurance Manager

We are currently seeking a highly motivated and experienced Quality Assurance Manager to lead our commitment to quality, operational efficiency, and excellence at Med Lit Solutions in Garner, NC. As the QA Manager, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and play will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility.

• Manage and maintain the site Quality Management System (QMS) in alignment with industry standards and organizational objectives.
• Lead all quality initiatives at the plant to ensure products consistently meet or exceed defined quality standards and customer expectations.
• Collaborate with cross-functional teams to identify opportunities for quality improvements, process optimization, and cost-effectiveness.
• Ensure timely investigation, resolution, and closure of quality workflows like Complaints, CAPA, NCR etc.
• Conduct internal audits and assessments to evaluate the effectiveness of the QMS and operational processes, identifying areas for improvement.
• Monitor and report on key performance indicators (KPIs).
• Ensure compliance with local regulations and industry standards applicable to pharmaceutical packaging and printing.
• Provide training, coaching, and mentorship to employees to strengthen understanding of quality principles, tools, and best practices.
• Oversee supplier quality management activities, including supplier evaluations and audits, to ensure incoming materials meet quality requirements.
• Regularly communicate with customers and internal stakeholders regarding quality initiatives and processes.
• Partner with the Plant Manager to promote a culture of quality excellence, accountability, and continuous improvement.
• Perform other duties as assigned.

• Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
• Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with minimum 3 years managing direct reports and leading teams.
• Expertise in ISO 9001 (Quality Management Systems).
• Experience with FSC, SFI and PEFC certifications a plus.
• Understanding of FDA pharmaceutical and Medical Device industry regulations a plus.
• Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions.
• Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders.
• Proficiency in quality management systems, data analysis tools, and software applications.
• QCBD Software Experience is a plus.
• Lean Six Sigma certification is a plus.