... Management System) and Regulatory Requirements. · Collaborating with engineering and production teams to resolve quality issues. Support engineering during investigations. · CAPA (Corrective and ...
Quick apply
... Management System) and Regulatory Requirements. · Collaborating with engineering and production teams to resolve quality issues. Support engineering during investigations. · CAPA (Corrective and ...
Quick apply
... Management System) and Regulatory Requirements. · Collaborating with engineering and production teams to resolve quality issues. Support engineering during investigations. · CAPA (Corrective and ...
Juncos, PR · On-site
Responsible for managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment/system Root Cause Analysis investigations and support trend ...
Juncos, PR · On-site
Responsible for managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment/system Root Cause Analysis investigations and support trend ...
Strong knowledge of risk management, CAPA systems, supplier oversight, and inspection readiness. * Strong executive communication and influencing skills. What you can expect of us As we work to ...
Strong knowledge of risk management, CAPA systems, supplier oversight, and inspection readiness. * Strong executive communication and influencing skills. What you can expect of us As we work to ...
Juncos, PR · On-site
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
Juncos, PR · On-site
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
PR · On-site
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
PR · On-site
$25 - $35/hr
Root Cause Analysis & CAPA: Perform root cause analysis for automation incidents, support ... Knowledge of Kneat Software or equivalent validation management tools. SKILLS Technical Skills
Quick apply
PR · On-site
$25 - $35/hr
Root Cause Analysis & CAPA: Perform root cause analysis for automation incidents, support ... Knowledge of Kneat Software or equivalent validation management tools. SKILLS Technical Skills
Dorado, PR · On-site
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Dorado, PR · On-site
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Juncos, PR · On-site
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
Juncos, PR · On-site
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
Quick apply
$101K - $139K/yr
... management involved . Position Summary The Senior Engineer is responsible for providing advanced ... Develop and implement corrective and preventive actions ( CAPA). * Drive continuous improvement ...
Dorado, PR · On-site
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Quick apply
Dorado, PR · On-site
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...
Position Summary We are seeking a Project Manager to lead strategic, cross-functional initiatives ... CAPA systems * Proven ability to collaborate across cross-functional teams * Experience with:
Position Summary We are seeking a Project Manager to lead strategic, cross-functional initiatives ... CAPA systems * Proven ability to collaborate across cross-functional teams * Experience with:
$28 - $33/hr
Non-Conformance Management and CAPA * Ensure non-conformances are triaged within established timelines. * Author and support investigation reports. * Execute and track corrective and preventive ...
Quick apply
$28 - $33/hr
Non-Conformance Management and CAPA * Ensure non-conformances are triaged within established timelines. * Author and support investigation reports. * Execute and track corrective and preventive ...
Juncos, PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
Juncos, PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
Quick apply
PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
PR · On-site
Provide leadership and guidance for validation related CAPA activities. * Member of the Quality Risk Management and participate in development of FMEAs and Risk Control Plans as validation SME.
Juncos, PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
Juncos, PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
Quick apply
PR · On-site
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...
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.

Full-time
Posted 18 days ago
Job Summary:
Ensuring product quality and compliance with IMS (Integrated Management System,), ISO 9001 and industry standards. Responsible for ensuring the quality of photovoltaic module through rigorous inspection and testing processes.
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Key Responsibilities:
· Conduct incoming raw material inspection and in-process checks.
· Perform electrical and visual testing of solar modules.
· Monitor Production processes to ensure compliance with quality standards.
· MRB (Material Review Board): Inspecting and documenting non-conforming materials, assisting in disposition decisions, and implementing rework or scrap actions. Support designing rework procedures.
· Prepare detailed inspection reports and quality documentation.
· Implement and maintain QA QC procedures and protocols.
· SCAR (Supplier Corrective Action Request): Gathering data on supplier defects, assisting in investigations, and verifying corrective actions.
· Performing audits to maintain quality assurance protocols. Comply with IMS (Integrated Management System) and Regulatory Requirements.
· Collaborating with engineering and production teams to resolve quality issues. Support engineering during investigations.
· CAPA (Corrective and Preventive Action): Conducting root cause analysis, implementing corrective actions, and monitoring effectiveness.
· Leading investigations and site audits to ensure regulatory compliance.
· Providing lot disposition and authorizing shipments.
· Supporting automation, facilities, and environmental programs.
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Requirements:
Associate degree or at least three years’ experience in Quality Management System
knowledge in ISO 9001, 140001, 45001, Internal Audit
Document Management and Change Management process
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Qualifications:
· Attention to details and excellent communication abilities
· Familiarity with testing equipment
· Strong Analytical and problem solving skills
· Experience with CAPA (Corrective and Preventive Actions) and Nonconformance Reports (NR).
· Familiarity with MRB (Material Review Board) processes.
· Experience with CAR/SCAR (Corrective Action Request)