Quality Systems Engineer (Med Device) in San Diego, CA at Apex Life Sciences

Date Posted: 6/1/2018

Job Snapshot

Job Description


Our Client, a leader in rapid point of care diagnostics is seeking a Quality System Engineer

Position Summary

Under minimum supervision of the supervision of the Director, Quality Assurance & Regulatory Compliance (QA/RC), the Quality System Associate is responsible for ensuring compliance and continuous improvements for business processes relating to the Quality Management System.  Primary responsibilities include: site compliance to applicable Standards and Regulations; validations; internal, external and supplier audits; supplier evaluations; control of nonconforming products; control of measuring devices; document control; monitoring of infrastructure and work environment; CAPA; and diverse QA/RC administrative tasks.

Duties and Responsibilities

  • Support the Deputy Management Representative in its role for implementing and maintaining a compliant Quality System per FDA and ISO requirements throughout the North America Distribution Centers.
  • Implement and manage the Incoming Quality Control Laboratory at the Distribution Center
  •  Incorporate Legal Manufacturer incoming Quality Control inspection SOPs under the Distribution Center Quality Management System.
  • Oversee record maintenance program for the Quality Control inspection
  • Support modification, continual improvement and maintenance of the existing Quality System of the Distribution Center
  • Perform gap assessment and Implement Corporate Policy requirements under the Quality system of the Distribution Center.
  • Is involved in the Document Control system including the writing of new Quality System documents or maintenance of existing documents, processing document change requests and coordinating the approval of SOPs, Work Instructions and Forms.
  • Document and execute validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Center or other sites as needed.
  • Interface with the Legal Manufacturers and Regulatory owners for the review, and approval of product regulatory labeling work order.
  • Perform first and last article inspection as well as in process inspection based on AQL sampling.
  • Execute applicable Quality Management System processes, monitor the processes’ efficiency through QC inspections, and personify the spirit of the Quality Policy. Inspect ADSD on a daily basis and report immediately any non-conformance against the applicable requirements. Inspect all quarantine areas on a daily basis to confirm compliance to products on-hold in the ERP. Follow up on inspections when needed.
  • Analyze all sources of nonconformities and variances to identify trends and escalate to the incident or CAPA system as appropriate.
  • Support the calibration program at ADSD. Ensure unique identification and on-time calibration of all measuring equipment, and maintain calibration files in ManagerPlus.
  • Confirm proper functioning of the ADSD temperature monitoring system (main and backup) on a monthly basis through testing activities. Maintain records of testing in ManagerPlus.
  • Review and maintain NCR, rework, CAPA and other QA trend reports as instructed in the document management system.
  • Execute Quality System Improvement Plans (QSIP) for the implementation of new elements or changes to the existing Quality System

Minimum Skills, Competencies and Qualifications

  • Very good Knowledge of Medical Device regulations and associated standards, e.g. QSR’s, ISO 9001, ISO 13485 is required.
  • Certified Quality System Auditor preferred
  • Demonstrated ability to carry out assignments in a timely, accurate manner, following directions and accomplishing tasks as required.
  • Must have hands-on experience with Microsoft Office Suite (e.g. Excel, Word, PowerPoint, etc.) and Enterprise Resource Planning (ERP) Systems, SAP preferred.
  • Data reporting, trending and analysis.
  • Knowledge of import/export regulations is a plus

Education & Experience

  • BA/BS preferred or equivalent experience required.
  • 5 years of experience preferred in Quality Management System
  • Experience in a production / distribution, cGMP, type environment preferred.
  • Experience with IVD products is a plus.

This position is based in San Diego and may require up to 20% of travel

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