Supplier Corrective Action & Preventive Action (CAPA) management * Supplier Process audit and report documentation if required * Support for alternate supplier identification, qualification
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Supplier Corrective Action & Preventive Action (CAPA) management * Supplier Process audit and report documentation if required * Support for alternate supplier identification, qualification
Quick apply
Supplier Corrective Action & Preventive Action (CAPA) management * Supplier Process audit and report documentation if required * Support for alternate supplier identification, qualification
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Indianapolis, IN · On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes, and ... Experience with electronic quality management systems (e.g., TrackWise, Veeva QMS) and lab ...
Draft CAPA plans that are risk-appropriate, measurable, and linked to verified root causes, and ... Experience with electronic quality management systems (e.g., TrackWise, Veeva QMS) and lab ...
Indianapolis, IN · On-site
$41/hr
This includes monitoring and completing CAPA (Corrective and Preventive Action) items, coordinating access management and account secret rotations, supporting operational needs, initiating change ...
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Indianapolis, IN · On-site
$41/hr
This includes monitoring and completing CAPA (Corrective and Preventive Action) items, coordinating access management and account secret rotations, supporting operational needs, initiating change ...
What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
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What You Will Do The Research Quality Assurance (QA) Manager is responsible for: * Creation ... CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly. * Prepare and ...
Indianapolis, IN · On-site
Experience with root cause investigations and CAPA development. * Proficiency in Microsoft Word, Excel, and electronic document management systems. Preferred Skills * Excellent technical writing and ...
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Indianapolis, IN · On-site
Experience with root cause investigations and CAPA development. * Proficiency in Microsoft Word, Excel, and electronic document management systems. Preferred Skills * Excellent technical writing and ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
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Investigations, CAPA & Quality Systems * Lead or provide management oversight for laboratory investigations associated with OOS, OOT, and non-conformance events, applying systematic troubleshooting ...
Noblesville, IN · On-site
$67K - $87K/yr
Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.). * Identify and implement activities geared to standardize and ...
Noblesville, IN · On-site
$67K - $87K/yr
Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.). * Identify and implement activities geared to standardize and ...
Manages and supports CAPA and NCR investigations, including tracking, documentation, effectiveness checks, and closure. * Reviews and approves quality system documentation, including procedures, work ...
Manages and supports CAPA and NCR investigations, including tracking, documentation, effectiveness checks, and closure. * Reviews and approves quality system documentation, including procedures, work ...
Greenfield, IN · On-site
Corrective and preventive actions (CAPA) * Develop remediation plans and evaluate training effectiveness. LMS Administration * Manage LMS course configuration and curricula. * Maintain training ...
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Greenfield, IN · On-site
Corrective and preventive actions (CAPA) * Develop remediation plans and evaluate training effectiveness. LMS Administration * Manage LMS course configuration and curricula. * Maintain training ...
Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation * Ensure compliance with FDA, cGMP, GDP, and internal quality management ...
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Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation * Ensure compliance with FDA, cGMP, GDP, and internal quality management ...
Indianapolis, IN · On-site
... CAPA, Nonconformance, and root cause investigations. • Familiarity with PLM systems such as Windchill, or Teamcenter. • Experience with Cockpit Cognition DHF Build and DHF traceability management ...
Indianapolis, IN · On-site
... CAPA, Nonconformance, and root cause investigations. • Familiarity with PLM systems such as Windchill, or Teamcenter. • Experience with Cockpit Cognition DHF Build and DHF traceability management ...
Corrective and preventive actions (CAPA) * Develop remediation plans and evaluate training effectiveness. LMS Administration * Manage LMS course configuration and curricula. * Maintain training ...
Corrective and preventive actions (CAPA) * Develop remediation plans and evaluate training effectiveness. LMS Administration * Manage LMS course configuration and curricula. * Maintain training ...
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.
Contractor
Re-posted 14 days ago
Role: Supplier Quality Engineer
Location: Indianapolis, IN
Duration: 6+ Months
JD:
• This position will work as an interface between the supplier and Customer plant sourcing, supplier quality and inspection areas
• Conduct PPAP planning with Suppliers as per CQP
• Follow up, expedition to meet development timelines
• Work Closely all Product Deviation notice and work for resolutions
• Supplier Corrective Action & Preventive Action (CAPA) management
• Supplier Process audit and report documentation if required
• Support for alternate supplier identification, qualification
• Facilitate escalation of unresolved supplier quality issues within assigned projects and suppliers
• First Article Inspection (FAI) at supplier facility / remotely as per Customer guidelines
• Support the plant Quality Manager to monitor and report on supplier product quality and performance
• Report on Key Performance Indicators (KPIs)
• Recommendations for areas of supplier focus.
Generally, Sheetmetal, machined, Plastics, Rubber, Electrical / Electro-mechanical components
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Our team of experts first gather each and every requirement of yours. Our research and development team then sit around those requirements and come up with a plan. Our implementation team then executes that plan for optimal results. After that our support team remains in constant touch with you during and after the entire process.
It services
201 - 500 Employees
Edison, NJ, US
2005