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QA Associate I
Ref No.: 18-15946
Location: San Diego, California
Intake Answers attached, JD Below
3-6 Months from start, possible extension, possible conversion
Monday-Friday 8-5

Job Summary:
The Quality Assurance is responsible for review and approval of in process and final product documentation to ensure that the documentation is aligned with existing specifications and quality standards. The QA Associate will review Device History Records prior to release. The QA Associate will also perform inspection of incoming raw materials, including dimensional analysis, visual inspection, and Certificate review. This position requires a high level of attention to detail, as the QA Associate is responsible for strictly adhering to the organization's quality assurance policies, and identifying defects and or production errors in order to prevent these materials from entering the supply chain.

Tasks and responsibilities:
The responsibilities for this position include but are not limited to the following:
• Performs review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices.
• Scans and maintains all Device History Records.
• Issues Certificates or Compliance and Certificates of Analysis for all Finished Good Lots.
• Approves the release of materials to next step in the process.
• Rejects subassemblies or finished products as required.
• Inspects raw materials and performs release of incoming materials and applicable documentation (e.g. packing slips or Certificates of Analysis) for compliance to established procedures and Good Documentation Practices.
• Conducts and documents process and system audits using written procedures as audit standards.
• Maintains all controlled document files and test records in a timely and accurate manner.
• Participates in the construction and/or revision of SOPs for the Quality Assurance function.
• Assists in the writing and updating inspection procedures, protocol, and checklists.
• Generates Quality Incidents where required for identified non-conformances.
• Evaluates problems and makes initial recommendations for possible corrective action
• Works with production management and Quality Control to provide feedback regarding accuracy of procedures and documentation improvement.
• Be capable of assessing current processes and making continuous improvements.
• Develops, reviews, and maintains metrics in relation to tasks assigned.

Note: Duties are not limited to those listed above. Additional duties may be assigned as required.

Preferred educational and experience:
· High School Diploma; or combination of education and work experience acceptable to Ameditech.
· Previous experience within a medical device or pharmaceutical environment is an asset.
· Proficiency in Microsoft Excel and Microsoft Word