Sr Clinical Quality Associate
Plano, TX · On-site
This role spans study support, CAPA management, and internal/external audit preparation and ... projects. • Generates CAPA documentation including investigations, resolution plans, and ...
Plano, TX · On-site
This role spans study support, CAPA management, and internal/external audit preparation and ... projects. • Generates CAPA documentation including investigations, resolution plans, and ...
Plano, TX · On-site
This role spans study support, CAPA management, and internal/external audit preparation and ... projects. • Generates CAPA documentation including investigations, resolution plans, and ...
Houston, TX · On-site
Maintain and improve the site QMS (including NCR and CAPA system, internal audit, training, etc ... Drive cross functional projects with manufacturing, supply chain, and engineering, to verify and ...
Houston, TX · On-site
Maintain and improve the site QMS (including NCR and CAPA system, internal audit, training, etc ... Drive cross functional projects with manufacturing, supply chain, and engineering, to verify and ...
Track, report, and sustain CI project results using KPIs and performance dashboards ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration
Track, report, and sustain CI project results using KPIs and performance dashboards ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration
Lead and mentor Green Belt-level projects and support Black Belt-level initiatives focused on ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration
Lead and mentor Green Belt-level projects and support Black Belt-level initiatives focused on ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration
Houston, TX · On-site
... Project Management, Operations, and Customer-facing teams to improve system reliability, reduce ... CAPA closure rate, and warranty cost drivers. · Partner with Project Engineering and Product ...
Houston, TX · On-site
... Project Management, Operations, and Customer-facing teams to improve system reliability, reduce ... CAPA closure rate, and warranty cost drivers. · Partner with Project Engineering and Product ...
Test & FA Engineering Assistant Manager (G-Project) TheTest & Failure Analysis (FA) Engineering ... Lead root cause investigations, corrective and preventive actions (CAPA), and repair-related ...
Test & FA Engineering Assistant Manager (G-Project) TheTest & Failure Analysis (FA) Engineering ... Lead root cause investigations, corrective and preventive actions (CAPA), and repair-related ...
Drive effective corrective and preventive actions (CAPA) for internal, supplier, and customer ... Drive productivity, quality, and cost reduction projects across manufacturing operations. Customer ...
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Drive effective corrective and preventive actions (CAPA) for internal, supplier, and customer ... Drive productivity, quality, and cost reduction projects across manufacturing operations. Customer ...
Jourdanton, TX · On-site
Lead root cause analysis and corrective/preventive action (CAPA) processes across sites. * Partner ... project, every time.
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Jourdanton, TX · On-site
Lead root cause analysis and corrective/preventive action (CAPA) processes across sites. * Partner ... project, every time.
This role supports product quality monitoring, non-conformance resolution, CAPA management ... Make independent decisions within assigned project areas to drive quality outcomes and operational ...
This role supports product quality monitoring, non-conformance resolution, CAPA management ... Make independent decisions within assigned project areas to drive quality outcomes and operational ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Round Rock, TX · On-site
$82K - $111K/yr
... CAPA. * Experience working within ISO 9001 quality management systems. * Demonstrated success leading cross-functional teams and driving improvement initiatives. * Strong communication, project ...
Houston, TX · On-site
... CAPA, and 8D processes. * Monitor site quality KPIs and trends and present data-driven ... Effective project management and organizational skills. * Strong technical writing and ...
Houston, TX · On-site
... CAPA, and 8D processes. * Monitor site quality KPIs and trends and present data-driven ... Effective project management and organizational skills. * Strong technical writing and ...
Ensure CAPA actions are properly defined, implemented, and validated for effectiveness. * Identify ... Knowledge Management & Lessons Learned * Capture and document RCAs, CAPAs, and improvement projects ...
Ensure CAPA actions are properly defined, implemented, and validated for effectiveness. * Identify ... Knowledge Management & Lessons Learned * Capture and document RCAs, CAPAs, and improvement projects ...
Lead and mentor Green Belt-level projects and support Black Belt-level initiatives focused on ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration ...
Lead and mentor Green Belt-level projects and support Black Belt-level initiatives focused on ... Implement and verify corrective and preventive actions (CAPA). Cross-Functional Collaboration ...
Lead root cause analysis (RCA) and develop effective corrective and preventive action plans (CAPA ... Experience with project management software (e.g., Procore, Primavera P6) and strong skills in ...
Lead root cause analysis (RCA) and develop effective corrective and preventive action plans (CAPA ... Experience with project management software (e.g., Procore, Primavera P6) and strong skills in ...
Houston, TX · On-site
... CAPA, and 8D processes. * Monitor site quality KPIs and trends and present data-driven ... Effective project management and organizational skills. * Strong technical writing and ...
Houston, TX · On-site
... CAPA, and 8D processes. * Monitor site quality KPIs and trends and present data-driven ... Effective project management and organizational skills. * Strong technical writing and ...
Lead root cause analysis (RCA) and develop effective corrective and preventive action plans (CAPA ... Experience with project management software (e.g., Procore, Primavera P6) and strong skills in ...
Lead root cause analysis (RCA) and develop effective corrective and preventive action plans (CAPA ... Experience with project management software (e.g., Procore, Primavera P6) and strong skills in ...
Waller, TX · On-site
The Facilities Engineer acts as a project manager for construction, renovation, FMP (factory master ... CAPA) • Lead or support small-to-medium capital projects (e.g., equipment upgrades, layout ...
Waller, TX · On-site
The Facilities Engineer acts as a project manager for construction, renovation, FMP (factory master ... CAPA) • Lead or support small-to-medium capital projects (e.g., equipment upgrades, layout ...
Houston, TX · On-site
Support corrective and preventive action (CAPA), Failure Mode and Effects Analysis (FMEA), Design ... Experience managing engineering capital projects, budgets, and resource planning. * Advanced ...
Houston, TX · On-site
Support corrective and preventive action (CAPA), Failure Mode and Effects Analysis (FMEA), Design ... Experience managing engineering capital projects, budgets, and resource planning. * Advanced ...
| Aspect | Capa Project Manager | Capa Coordinator |
|---|---|---|
| Certifications | Project Management Professional (PMP), CAPA certifications often preferred | CAPA-related certifications, some project management knowledge |
| Work Environment | Oversees multiple projects, manages teams, strategic planning | Supports CAPA activities, handles documentation, assists project managers |
| Employer & Industry | Pharmaceutical, Medical Devices, Manufacturing | Same industries, more focused on CAPA process execution |
The Capa Project Manager typically leads CAPA projects, coordinating teams and ensuring strategic goals are met. The Capa Coordinator supports the CAPA process by managing documentation and assisting project managers. Both roles require CAPA knowledge, but the Project Manager has broader responsibilities and leadership duties.
Cities in Texas with the most Capa Project Manager job openings:

Plano, TX • On-site
Other
This job post has expired 4 days ago. Applications are no longer accepted.
The Senior Clinical Quality Associate supports clinical affairs personnel globally in ensuring compliance with medical device and Google Cloud Platform regulations and standards, as well as applicable company policies and procedures. This role spans study support, CAPA management, and internal/external audit preparation and execution.
Key Responsibilities• Reviews study documents for compliance with applicable regulations, standards, and internal procedures.
• Acts as a compliance resource to clinical study teams regarding applicable regulations, standards, and procedures.
• Supports compliant execution of clinical research projects.
• Generates CAPA documentation including investigations, resolution plans, and implementation reports; drives resolution cross-functionally.
• Drives continuous process improvement and ensures work complies with regulatory and compliance standards.
• Serves as a key player in preparation and overall support for internal and external audits, including responding to audit findings through the CAPA process.
• May perform internal compliance assessments and/or audits.
• Supports project teams in preparation for regulatory authority inspections or audits.
• May support additional clinical quality tasks as needed.
Required Qualifications• Bachelor’s degree in a related field, or an equivalent combination of education and work experience.
• Minimum 4 years of related work experience with a solid understanding of clinical quality or Google Cloud Platform compliance functions.
• Strong understanding of Good Clinical Practice (Google Cloud Platform) including U.S. regulations (21 CFR Parts 50, 54, 56, 812) and international standards (ISO 14155).
• Strong written communication skills and independent decision-making ability.
• Effective problem-solving and planning skills; able to work independently under minimal supervision.
Preferred Qualifications• Minimum 5 years of experience in medical devices, clinical research, or a related industry.
• Minimum 3 years in a quality role within a medical device or clinical trial environment.
• Google Cloud Platform audit experience strongly preferred.
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It services
11 - 50 Employees
Kearny, NJ, US
2014