PAVmed Inc.
Quality Manager – PAVmed Inc.
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General Summary The Quality Manager is responsible for implementing and enforcing the company's quality management system. The role covers Quality Control, Quality Assurance, and Regulatory activities as applicable.
Job Responsibilities
Implement quality activities required to obtain and maintain ISO 13485, MDSAP, and CE Mark QMS certification.
Collaborate with internal and external team members on regulatory correspondence for changes to the business or products and regulatory audits.
Execute tasks including evaluating regulatory changes and leading Management Review meetings.
Maintain the Quality Management System by managing documentation control, quality training, internal and supplier audits, and customer support complaint communications, including CAPAs, complaints, and recalls.
Support Design Control project management, including construction of Design History Files for FDA submissions.
Collaborate with Development and Marketing to execute assigned tasks.
Partner with Engineering and Clinical departments on product development—risk management, usability, SaMD lifecycle, cybersecurity, and technical files.
Oversee post‑market surveillance activities: complaints, performance monitoring, and continuous improvement.
Ensure manufacturing and release quality through inspections, DHRs, equipment assessments, and validation support.
Support the implementation of short‑ and long‑range departmental goals, objectives, policies, and operating procedures as part of Management.
Guide individuals and departments in establishing, using, and improving the Quality Management System.
Other Duties and Responsibilities Occasional travel for team meetings, conferences, and vendor visits.
Qualifications
Bachelor's degree in engineering, Life Sciences, or a related field.
7+ years of experience in the medical devices industry with strong knowledge of design controls and quality systems.
Proven track record in leading cross‑functional continuous improvement projects.
Experience in QA systems implementation and maintenance.
Deep understanding of regulatory standards (FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR, ISO 14971, IEC 62304, etc.).
Experience implementing SDLC best practices in regulated environments.
Experience obtaining ISO certification is a strong plus.
Self‑motivated with ability to accomplish multiple assignments simultaneously.
Strong organizational and problem‑solving skills.
Detail‑oriented.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Medical Device
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General Summary The Quality Manager is responsible for implementing and enforcing the company's quality management system. The role covers Quality Control, Quality Assurance, and Regulatory activities as applicable.
Job Responsibilities
Implement quality activities required to obtain and maintain ISO 13485, MDSAP, and CE Mark QMS certification.
Collaborate with internal and external team members on regulatory correspondence for changes to the business or products and regulatory audits.
Execute tasks including evaluating regulatory changes and leading Management Review meetings.
Maintain the Quality Management System by managing documentation control, quality training, internal and supplier audits, and customer support complaint communications, including CAPAs, complaints, and recalls.
Support Design Control project management, including construction of Design History Files for FDA submissions.
Collaborate with Development and Marketing to execute assigned tasks.
Partner with Engineering and Clinical departments on product development—risk management, usability, SaMD lifecycle, cybersecurity, and technical files.
Oversee post‑market surveillance activities: complaints, performance monitoring, and continuous improvement.
Ensure manufacturing and release quality through inspections, DHRs, equipment assessments, and validation support.
Support the implementation of short‑ and long‑range departmental goals, objectives, policies, and operating procedures as part of Management.
Guide individuals and departments in establishing, using, and improving the Quality Management System.
Other Duties and Responsibilities Occasional travel for team meetings, conferences, and vendor visits.
Qualifications
Bachelor's degree in engineering, Life Sciences, or a related field.
7+ years of experience in the medical devices industry with strong knowledge of design controls and quality systems.
Proven track record in leading cross‑functional continuous improvement projects.
Experience in QA systems implementation and maintenance.
Deep understanding of regulatory standards (FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR, ISO 14971, IEC 62304, etc.).
Experience implementing SDLC best practices in regulated environments.
Experience obtaining ISO certification is a strong plus.
Self‑motivated with ability to accomplish multiple assignments simultaneously.
Strong organizational and problem‑solving skills.
Detail‑oriented.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Medical Device
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