QA/QC Manager

Job Title : QA / QC Manager

Location : Jersey City, NJ

Type : Direct Hire

Hours : Monday-Friday 9AM-5PM

Job Summary :

We are seeking an experienced detail-oriented QA / QC Manager with at least 5 years of experience 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.

Responsibilities :

• 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 :