Robert Half Technology CAPA Specialist II - Part Time in San Diego, California

Robert Half Technology has an upcoming need for a CAPA Specialist II, 1 year, part-time contract in San Diego. The CAPA Specialist II is responsible for ensuring the CAPA system is being managed effectively as part of the CAPA Administration group. They must work well with others in the organization to ensure Quality System processes are compliant to internal and external requirements. PART TIME- working 8-5 on Tuesdays and Thursday, potentially Monday, Wednesday, Fridays on 1/2 days. Approximately 20 hours/week Tasks and responsibilities:

  • Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.

  • Support and guide the CAPA Board and Users regarding the CAPA process, CAPA record content, and CAPA software

  • Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training

  • Ensure implementation and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.

  • Track CAPA process metrics to support improvement activities and management review.

  • Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.

  • Participate in problem solving efforts to resolve recurring and new quality issues in order to ensure production of safe and effective medical devices. Apply problem solving techniques to problems of moderate scope and complexity.

  • Critical Review of documents.

  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

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Req ID: 04810-9500777325

Functional Role: Account Executive/Staffing Manager

Country: USA

State: CA

City: San Diego

Postal Code: 92121

Compensation: DOE

Requirements: Requirements:

  • Must have at least 2 to 4 years' experience working in a professional environment where compliance was of vital importance.

  • Knowledge of the QSR or ISO 13485 is a plus.

  • Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.

  • Excellent organization skills – must be able to manage a large number of simultaneous projects

  • Attention to detail – must have precision in their work, especially as it relates to understanding and documenting complex quality issues

  • Excellent writing skills – must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.

  • Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources throughout the organization

  • Excellent critical analytical skills – ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue Email your resume to