QA/QC Manager

Job Summary
Our client is seeking an experienced detail-oriented QA/QC Manager with at least 5 years of experience as a licensed pharmacist in the medical device industry. This role is critical in ensuring product quality and regulatory compliance while fostering continuous improvement across the company. The QA/QC Manager will oversee quality assurance and quality control operations while driving excellence in the manufacturing processes and compliance with global standards.

• Develop, implement, and maintain the QMS in alignment with ISO13485 and other global standards.
• Establish, document, and enforce quality policies, procedures, and SOPs.
• Lead internal and external audits, including supplier audits, regulatory inspections, ensuring compliance and timely resolution of non-conformities.
• Manage change control processes and ensure proper validation of new equipment, processes, and systems.
• Oversee QC processes for raw materials, in process products, and finished products to ensure compliance with specifications.
• Analyze quality metrics and trends to identify potential risks and implement corrective actions.
• Collaborate with the production team to resolve quality issues and implement preventative measures.
• Maintain up-to-date knowledge of regulatory requirements for medical devices, including ISO standards and FDA regulations.
• Ensure product documentation and labeling meet regulatory requirements.
• Prepare for and participate in regulatory submissions, inspections, and audits.
• Lead, mentor, and manage the QA/QC team to meet organizational quality objectives.
• Provide training to staff on quality standards, compliance, and operational excellence.
• Foster a culture of quality and continuous improvement across the organization.
• Identify opportunities for process optimization and cost efficiency while maintaining high quality standards.

Requirements:
• Minimum of 5 years of experience as a NJ licensed pharmacist in the medical device industry.
• Bachelor’s degree in Pharmacy, Master’s degree a plus.
• Strong knowledge of ISO 13485 and other global regulatory standards for medical devices.
• Experience in managing quality audits, regulatory inspections, and compliance programs.
• Proficient in quality tools such as CAPA and statistical analysis/reporting.
• 5 Years of Supervisory Experience (Team of 4)
• Excellent leadership, communication, and problem-solving skills.