Lynchburg, VA · On-site
This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure ...
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Lynchburg, VA · On-site
This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure ...
Lynchburg, VA · On-site
This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure ...
Quick apply
Lynchburg, VA · On-site
This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure ...
CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions ...
CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions ...
Richmond, VA · On-site
CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions ...
Richmond, VA · On-site
CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Manassas, VA · On-site
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Manassas, VA · On-site
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Manassas, VA · On-site
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
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Manassas, VA · On-site
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
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Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Chantilly, VA · On-site
$115K/yr
... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...
Leesburg, VA · On-site
$125K - $135K/yr
Mentor others on industry standards, design requirements, test strategies, design controls, risk management, and NC/CAPA processes * Identify and implement improvements to reduce cost, increase ...
Leesburg, VA · On-site
$125K - $135K/yr
Mentor others on industry standards, design requirements, test strategies, design controls, risk management, and NC/CAPA processes * Identify and implement improvements to reduce cost, increase ...
Richmond, VA · On-site
Previous supervisory or management experience in a manufacturing environment required * Strong knowledge of quality systems, inspections, root cause analysis, CAPA, and continuous improvement ...
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Richmond, VA · On-site
Previous supervisory or management experience in a manufacturing environment required * Strong knowledge of quality systems, inspections, root cause analysis, CAPA, and continuous improvement ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
Chester, VA · On-site
$118K - $178K/yr
We are seeking a Quality Manager with proven experience in chemical manufacturing to lead our ... Experience with customer complaint handling and CAPA systems in a regulated environment.
... CAPA), and Training. * Support SOP development, gap closure documentation, and audit-readiness ... Contribute to the ongoing development of PMO tools, templates, and governance processes within ...
... CAPA), and Training. * Support SOP development, gap closure documentation, and audit-readiness ... Contribute to the ongoing development of PMO tools, templates, and governance processes within ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
Richmond, VA · On-site
Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management * Author and execute system validation documentation (e.g., URS, FRS, IQ ...
$14.25 - $19.75/hr
Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation and Capa management. * Excellent communication and interpersonal skills, with the ability to ...
$14.25 - $19.75/hr
Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation and Capa management. * Excellent communication and interpersonal skills, with the ability to ...
Norfolk, VA · On-site
$91K - $122K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium-to-large scale CI projects, ensuring ...
Norfolk, VA · On-site
$91K - $122K/yr
Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation ... Project Management * Plan, execute, and sustain medium-to-large scale CI projects, ensuring ...
A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.
One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.
To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.
Internal Auditors are responsible for conducting internal audits to ensure compliance with AS9001 and ISO13485 standards. This role involves evaluating the effectiveness of the Quality Management System (QMS), identifying areas for improvement and overseeing the Corrective and Preventive Actions (CAPA) process to ensure nonconformities are addressed effectively.
Job Duties
-Plan, schedule and conduct internal audits in accordance with AS9100, ISO9001 and ISO 13485 requirements
-Develop and maintain an internal audit schedule to ensure all areas of the QMS are audited reqularly
-Prepare audit checklists and documentation based on applicable standards, regulartory requirements and company procedures
-Conduct thorough audits, including interviews, document reviews and process observations
-Document audit findings, nonconformities and opportunities for improvement in detailed audit reports
-Communicate audit results to relevant stakeholders and follow up on corrective actions
-To reach clear and unambiguous conclusions based on audit observations and to remain true to the conclusions
-Being fair and impartial to relevant personnel during the audit
-Assist in the coordinating of the CAPA process, including the identification, documentation and investigation of nonconformities.
-Collaborate with cross-functional teams to perform root cause analysis and develop effective corrective and preventive actions
-Monitor the implementation and effectiveness of CAPAs to ensure timely resolution of issues
-Maintain CAPA records and ensure compliance with regulatory and company requirements
-Provide training and guidance to staff on CAPA processes and best practices
-Participate in management reviews and provide input on QMS performance and improvement opportunities
-Assist in preparing for external audits and regulatory inspections
-To conduct audits for Verification of Effectiveness on CAPA's
-Understand and apply all sections of AS9100, ISO9001 and ISO13485
Qualifications
Education:Atleast high school graduate. Previous audit experience preferred
Knowledge:Ability to communicate well with all roles within the organization, detailed oriented, good listener and communicator, good understanding of the Internal Standards and the importance of a good quality management system. Good work ethic.
Experience:Previous audit experience a plus as well as a strong interest in quality
Working Conditions:
Environment:Office Environment: Physical Requirements Must be able to remain in a stationary position 80% of the time, work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Must have the ability to lift and carry small parcels, packages and other items, to walk short distances.
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Medical equipment and supplies manufacturing
201 - 500 Employees
Lynchburg, VA, US
1997
