System One Holdings, LLC
QC Manager
System One Holdings, LLC, Jersey City, New Jersey, United States, 07390
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:
Minimum of 5 years of experience in the medical device industry, life sciences and a background in biology. Bachelor's degree, 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 Recent Supervisory Experience (Team of 4) Excellent leadership, communication, and problem-solving skills.
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:
Minimum of 5 years of experience in the medical device industry, life sciences and a background in biology. Bachelor's degree, 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 Recent Supervisory Experience (Team of 4) Excellent leadership, communication, and problem-solving skills.