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Quality Engineer

2 months ago

Lake Forest, United States Select Source International Full time
Job DescriptionJob Description

Job title: CAPA Process Analyst II

Location – Lake Forest IL

Other Location: Santa Rosa, CA 95403 / Gretna LA 70053

Progresses investigations and other activities through the CAPA program.

- Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.

- Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.

- Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business Behaviors are consistent with the Abbott Code of Conduct.

 

Main Responsibilities:

Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.

Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.

Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.

Provides leadership for the initiation of improvement activities associated with identified trends.

Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.

Ensures effective written and verbal communications.

Prioritizes workload in relation to the needs of the business.

Supports the attainment of Abbott Toxicology Laboratories goals and objectives.

Ensures compliance to organizational procedure, regulatory requirements and industry standards and timely completion of CAPAs and audit findings.

 

Required Qualifications:

Bachelor’s degree in engineering or Life Sciences

Experience with Corrective and Preventative Action process in medical devices or laboratories

Excellent communication and technical writing skills

 

Preferred Qualifications:

Understanding of statistics, FMEA and a ASQ CQE

Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations or similar regulated industry.

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.