Capa Jobs in Illinois (NOW HIRING)

Shift Supervisor needs to manage continuous improvement projects, R&D new product developments, CAPA (corrective action and preventive action), new hire development, associate accountability ...

Shift Supervisor needs to manage continuous improvement projects, R&D new product developments, CAPA (corrective action and preventive action), new hire development, associate accountability ...

Monitor quality metrics, customer feedback, CAPA trends, audit results, training compliance, and site deliverables to identify improvement opportunities. * Support supplier qualification, supplier ...

Monitor quality metrics, customer feedback, CAPA trends, audit results, training compliance, and site deliverables to identify improvement opportunities. * Support supplier qualification, supplier ...

Strengthen and standardize the CAPA system * Drive structured root cause analysis (5 Whys, Fishbone, etc.) * Manage quarantine inventory and material disposition * Close Supplier Corrective Action ...

Participate if needed as a NC and CAPA subject matter expert during internal and external audits. * Lead and/or support other duties as assigned. Required Education & Experience * Bachelor's Degree ...

Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance. * Ensure all products, processes, and records meet FDA, ISO 13485, and internal standards. * Collaborate cross ...

The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and ...

Drive root cause analysis and ensure effective CAPA implementation. * Maintain and continuously improve deviation investigation procedures and associated quality processes. * Provide technical ...

Lead the CAPA process for internal and customer complaints, CAPA meetings, issue CAPA numbers and update the CAPA log. * Maintain and own the document control process and issuing SOP's and Document ...

This role drives execution of corrective and preventive actions (CAPA), ensures compliance with applicable standards (e.g., ISO 13485, FDA, GMP), and restores sustainable quality system performance.

Manage the Regulatory Affairs Issue and CAPA Management (RAIM) system to ensure issues are accurately logged, assessed, tracked, and resolved in a timely and compliant manner. * Triage RAIM issue ...

This role drives execution of corrective and preventive actions (CAPA), ensures compliance with applicable standards (e.g., ISO 13485, FDA, GMP), and restores sustainable quality system performance.

Apply hands-on experience in CAPA and Production Pre-Approval processes. Qualifications * BS Degree; a background in Mechanical or Biotechnology is preferred. * 1 to 3 years of experience in relevant ...

Run quality event management end to end: nonconformance handling, risk assessment, root cause analysis, and CAPA, with verified, sustained closure. * Own quality KPIs -- track them, turn the data ...

Run quality event management end to end: nonconformance handling, risk assessment, root cause analysis, and CAPA, with verified, sustained closure. * Own quality KPIs -- track them, turn the data ...

Writes customer complaints and product investigations, helping to assess risk, identify root cause, CAPA plans, and implementing solutions with business partners. * Writes QMS documents, including ...

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

Teamcenter Quality modules (Non-Conformance, CAPA, Audit, FMEA integration) Design integrated solutions linking: Configurable product structures with quality processes and compliance Develop ...