February 10th, 2017

QA Engineer – Medical Devices & IVD Manufacturer, Los Angeles, CA

QA Engineer needed to manage the selection, qualification, and monitoring of suppliers including finished device, OEM, and contract manufacturers. This person will play a key role in working with suppliers to resolve quality issues (SCAPAs), resolving internal non-conforming product issues, addressing incoming inspection challenges, including development and review of inspection procedures, overseeing equipment calibration, maintenance and validation, and maintaining accurate and complete documentation of these activities in compliance with the requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.

Requirements

  • B.S. in in a technical discipline (i.e. science or engineering)
  • Five or more years of relevant experience in an FDA regulated industry
  • 3-5 years of which is in Quality Assurance
  • ASQ Certification as Quality Engineer (CQE) or equivalent, preferred

QA Engineer Responsibilities

  • Develop and administer a supplier quality auditing program
  • Frequently travel to suppliers to understand their processes and controls, verify controls are executed as planned, communicate issues, and work with them directly to improve processes and part quality
  • Obtain and maintain supplier process control information
  • Work with other departments and suppliers to resolve major quality issues as necessary
  • Implement and maintain an effective reporting system to identify the opportunities for improvement in supplier quality performance
  • Develop and maintain systematic reporting to suppliers on their quality performance
  • Manage and approve supplier changes
  • Review and resolve Material Review Board (MRB) issues through coordination of efforts across departments and at incoming inspection.
  • Monitor incoming inspection activities, including development and review of inspection procedures
  • Resolve Quality issues with product, working with Suppliers including on SCAPA’s and Audit Findings
  • Assist scientific staff in identifying and documenting requirements for new instruments and selecting equipment that meets requirements
  • Prepare protocols for installation, operational and performance qualification of instruments, direct the execution of these protocols and write the final reports
  • Write procedures for instrument operation, routine maintenance and calibration
  • Plan and schedule instrument maintenance and calibration performed by external vendors
  • Manage the environmental monitoring system, and coordinate responses and corrective actions to alarms and out-of-specification conditions
  • Respond to equipment malfunctions and coordinate repairs performed by external vendors
  • Maintain detailed records of equipment purchase, qualification, calibration, repair and maintenance in compliance with documented Quality System Procedures
  • Support New Product Development activities
  • Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Engineering activities

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Contact:
Paul Dionne
MEIRxRS
pdionne@meirxrs.com

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