BioLab Holdings, Inc.
Quality Auditor (Supplier and Internal)
BioLab Holdings, Inc., Arizona City, Arizona, United States, 85123
Description
Job Overview
:
The Quality Auditor shall be detail-oriented and an experienced Supplier and Internal Auditor and will be responsible for conducting audits of suppliers and internal processes to ensure compliance with regulatory standards and organizational policies. This position will help us maintain the integrity and quality of our products and services.
Essential Functions:
Supplier Audits:
Conduct regular audits of suppliers to evaluate their compliance with quality standards, regulatory requirements, and contractual obligations. Assess supplier quality management systems and processes, providing feedback and recommendations for improvement.
Internal Audits:
Plan, execute, and report on internal audits across various departments to ensure adherence to established quality management systems and operational procedures. Identify non-conformities and areas for improvement, and collaborate with teams to develop corrective action plans.
Documentation and Reporting:
Maintain accurate records of audit findings, reports, and follow-up actions. Prepare and present audit reports to management, highlighting key findings and trends.
Compliance Monitoring:
Monitor changes in regulatory requirements and industry standards, ensuring that the organization remains compliant. Assist in developing and updating internal policies and procedures in line with regulatory changes.
Collaboration and Training:
Work closely with cross-functional teams to promote a culture of quality and compliance. Provide training and support to staff on audit processes and quality standards.
Continuous Improvement:
Identify opportunities for process improvements and contribute to quality initiatives within the organization. Participate in quality improvement projects as needed.
Follow-Up Audits:
Conduct follow-up audits to ensure the effective implementation of corrective actions and improvements based on previous audit findings.
Ensure that corrective actions and preventive actions (CAPA) are implemented and documented. Maintain meticulous records of audit findings, corrective measures, and compliance status. Assist in the development and continuous improvement of quality assurance procedures. *
This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.
Qualifications:
Bachelor's degree in quality assurance, Biomedical Engineering, Life Sciences, or a related field. 8+ years of experience in auditing, quality assurance, or regulatory compliance, preferably in the medical device, biotech, or tissue banking industry. Certified Internal Auditor (CIA) or similar certification is required. Exceptional attention to detail and analytical skills. Strong knowledge of quality management systems (e.g., ISO 13485), regulatory standards, and auditing practices. Strong communication and interpersonal skills, with the ability to work collaboratively with various teams. Proficiency in Microsoft Office and Quality Management Systems (QMS). Strong communication skills for reporting and cross-departmental collaboration. Ability to work independently and prioritize tasks efficiently. Problem-solving mindset with the ability to adapt to evolving procedures. Flexibility to handle multiple tasks and changing priorities.
Job Overview
:
The Quality Auditor shall be detail-oriented and an experienced Supplier and Internal Auditor and will be responsible for conducting audits of suppliers and internal processes to ensure compliance with regulatory standards and organizational policies. This position will help us maintain the integrity and quality of our products and services.
Essential Functions:
Supplier Audits:
Conduct regular audits of suppliers to evaluate their compliance with quality standards, regulatory requirements, and contractual obligations. Assess supplier quality management systems and processes, providing feedback and recommendations for improvement.
Internal Audits:
Plan, execute, and report on internal audits across various departments to ensure adherence to established quality management systems and operational procedures. Identify non-conformities and areas for improvement, and collaborate with teams to develop corrective action plans.
Documentation and Reporting:
Maintain accurate records of audit findings, reports, and follow-up actions. Prepare and present audit reports to management, highlighting key findings and trends.
Compliance Monitoring:
Monitor changes in regulatory requirements and industry standards, ensuring that the organization remains compliant. Assist in developing and updating internal policies and procedures in line with regulatory changes.
Collaboration and Training:
Work closely with cross-functional teams to promote a culture of quality and compliance. Provide training and support to staff on audit processes and quality standards.
Continuous Improvement:
Identify opportunities for process improvements and contribute to quality initiatives within the organization. Participate in quality improvement projects as needed.
Follow-Up Audits:
Conduct follow-up audits to ensure the effective implementation of corrective actions and improvements based on previous audit findings.
Ensure that corrective actions and preventive actions (CAPA) are implemented and documented. Maintain meticulous records of audit findings, corrective measures, and compliance status. Assist in the development and continuous improvement of quality assurance procedures. *
This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.
Qualifications:
Bachelor's degree in quality assurance, Biomedical Engineering, Life Sciences, or a related field. 8+ years of experience in auditing, quality assurance, or regulatory compliance, preferably in the medical device, biotech, or tissue banking industry. Certified Internal Auditor (CIA) or similar certification is required. Exceptional attention to detail and analytical skills. Strong knowledge of quality management systems (e.g., ISO 13485), regulatory standards, and auditing practices. Strong communication and interpersonal skills, with the ability to work collaboratively with various teams. Proficiency in Microsoft Office and Quality Management Systems (QMS). Strong communication skills for reporting and cross-departmental collaboration. Ability to work independently and prioritize tasks efficiently. Problem-solving mindset with the ability to adapt to evolving procedures. Flexibility to handle multiple tasks and changing priorities.