Midas Management and Research
Manufacturing _Quality Assurance Manager _ Irwindale, CA 91706Job DescriptionSalary 100k-120k BaseTitle - Manufacturing _Quality Assurance ManagerJob DescriptionPosition Overview:
The Quality Assurance Manager of Manufacturing is responsible for leading and overseeing the quality assurance activities within the company's medical device manufacturing operations.
This role involves ensuring compliance with regulatory standards, maintaining product quality, and driving continuous improvement initiatives to enhance manufacturing processes.
Responsibilities:
Quality Management System (QMS)Develop, implement, and maintain a robust and compliant quality management system in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Monitor and enforce adherence to quality policies, procedures, and work instructions across all manufacturing processes.
Regulatory ComplianceStay current with FDA regulations and international medical device regulations to ensure the company's practices align with industry requirements.
Collaborate with regulatory affairs to prepare and submit regulatory documentation, including 510(k) submissions and other regulatory filings.
Product Quality AssuranceEnsure that manufactured medical devices meet or exceed quality standards, specifications, and performance requirements.
Implement robust inspection and testing processes to detect and prevent defects, deviations, and non-conformities.
Risk ManagementLead risk management activities for the production, identifying potential risks associated with manufacturing processes and products.
Develop and execute risk mitigation strategies to minimize product-related risks.
Supplier Quality ManagementCollaborate with the procurement team to assess and qualify suppliers based on quality and regulatory criteria.
Establish and maintain supplier quality agreements, conduct audits, and manage supplier corrective actions.
Internal and External AuditsPlan and coordinate internal audits to assess the effectiveness of the QMS and manufacturing processes.
Participate in audits and inspections by regulatory authorities, addressing findings and implementing corrective and preventive actions (CAPAs).
Continuous ImprovementDrive a culture of continuous improvement by identifying process inefficiencies and opportunities for optimization.
Lead cross-functional teams to implement process enhancements and ensure sustained quality improvement.
Document ControlOversee the creation, review, and revision of manufacturing and quality-related documents, ensuring accuracy and compliance.
Maintain an organized and up-to-date document control system.
Ensure accurate and comprehensive documentation of quality process, procedures, and production records.
Training and DevelopmentProvide training and guidance to manufacturing personnel on quality procedures, regulations, and best practices.
Foster a sense of ownership for quality among all employees.
Metrics and ReportingDevelop and present quality metrics and performance reports to senior management, highlighting key trends, achievements, and areas for improvement.
Qualifications:
Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred.
Significant experience (typically 5
years) in quality assurance within medical device manufacturing, with a strong understanding of FDA regulations and ISO 13485 standards.
Proven experience in leading quality improvement initiatives and managing cross-functional teams.
Proficiency in risk management methodologies and root cause analysis techniques.
Experience with internal and external audits, regulatory inspections, and interactions with regulatory agencies.
Detail-oriented mindset with a commitment to maintaining accurate records and documentation.
Proficiency in using quality management software and tools.
Strong communication, leadership, and team-building skills.
Excellent problem-solving skills and the ability to make sound decisions under pressure.
Quality management certification (e.
g.
, CQM, CMQ/OE) preferredAbout the Company:
Midas Management and Research.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Quality Assurance Manager of Manufacturing is responsible for leading and overseeing the quality assurance activities within the company's medical device manufacturing operations.
This role involves ensuring compliance with regulatory standards, maintaining product quality, and driving continuous improvement initiatives to enhance manufacturing processes.
Responsibilities:
Quality Management System (QMS)Develop, implement, and maintain a robust and compliant quality management system in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Monitor and enforce adherence to quality policies, procedures, and work instructions across all manufacturing processes.
Regulatory ComplianceStay current with FDA regulations and international medical device regulations to ensure the company's practices align with industry requirements.
Collaborate with regulatory affairs to prepare and submit regulatory documentation, including 510(k) submissions and other regulatory filings.
Product Quality AssuranceEnsure that manufactured medical devices meet or exceed quality standards, specifications, and performance requirements.
Implement robust inspection and testing processes to detect and prevent defects, deviations, and non-conformities.
Risk ManagementLead risk management activities for the production, identifying potential risks associated with manufacturing processes and products.
Develop and execute risk mitigation strategies to minimize product-related risks.
Supplier Quality ManagementCollaborate with the procurement team to assess and qualify suppliers based on quality and regulatory criteria.
Establish and maintain supplier quality agreements, conduct audits, and manage supplier corrective actions.
Internal and External AuditsPlan and coordinate internal audits to assess the effectiveness of the QMS and manufacturing processes.
Participate in audits and inspections by regulatory authorities, addressing findings and implementing corrective and preventive actions (CAPAs).
Continuous ImprovementDrive a culture of continuous improvement by identifying process inefficiencies and opportunities for optimization.
Lead cross-functional teams to implement process enhancements and ensure sustained quality improvement.
Document ControlOversee the creation, review, and revision of manufacturing and quality-related documents, ensuring accuracy and compliance.
Maintain an organized and up-to-date document control system.
Ensure accurate and comprehensive documentation of quality process, procedures, and production records.
Training and DevelopmentProvide training and guidance to manufacturing personnel on quality procedures, regulations, and best practices.
Foster a sense of ownership for quality among all employees.
Metrics and ReportingDevelop and present quality metrics and performance reports to senior management, highlighting key trends, achievements, and areas for improvement.
Qualifications:
Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred.
Significant experience (typically 5
years) in quality assurance within medical device manufacturing, with a strong understanding of FDA regulations and ISO 13485 standards.
Proven experience in leading quality improvement initiatives and managing cross-functional teams.
Proficiency in risk management methodologies and root cause analysis techniques.
Experience with internal and external audits, regulatory inspections, and interactions with regulatory agencies.
Detail-oriented mindset with a commitment to maintaining accurate records and documentation.
Proficiency in using quality management software and tools.
Strong communication, leadership, and team-building skills.
Excellent problem-solving skills and the ability to make sound decisions under pressure.
Quality management certification (e.
g.
, CQM, CMQ/OE) preferredAbout the Company:
Midas Management and Research.
Estimated Salary: $20 to $28 per hour based on qualifications.
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