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Lead Quality Assurance Inspector
Lead Quality Assurance InspectorIgnite Human Capital • San Diego, CA, US
Lead Quality Assurance Inspector

Lead Quality Assurance Inspector

Ignite Human Capital • San Diego, CA, US
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Job Description

Job Description

About the Opportunity

Coordinates the Quality Assurance Inspectors to inspect incoming materials, work in-process and finished goods in the production / assembly of dental parts / assemblies / finished goods to ensure conformance as defined by ISO 13485 : 2016, FDA regulated standards, customer specifications, and Argen requirements.

In this role, the successful candidate will :

  • Ensures Quality Inspection area is running efficiently.
  • Makes on-the-spot personnel adjustments to keep processes on times, and communicates all adjustments to the Supervisor.
  • Communicates clear instructions to team members.
  • Ensures safety guidelines are followed.
  • Facilitates team participation.
  • Acts as a liaison between inspectors and the Supervisor.
  • Assists the Supervisor to conduct and document training.
  • Ensures compliance to all applicable regulations to FDA, ISO, MDSAP, OSHA, etc.
  • Ensures completeness and accuracy of quality inspection documentation.
  • Assists inspectors by answering questions and demonstrating inspection processes.
  • Confirms all Quality Inspectors are up to date on their training requirements in Vivaldi.
  • Reinforces proper adherence to required Personal Protective Equipment (PPE) for the area.
  • Utilizes microscope, digital calipers, micrometer, optical comparator, vision measurement system, and other related equipment with optimal accuracy.
  • Provides in-process / final inspection and testing as required.
  • Provides inspection of outside processing (receiving inspection).
  • Maintains proper inspection and test records.
  • Assures that non-conforming material has been properly identified.
  • Advises the responsible production personnel of the acceptability of products or materials based on results of testing and / or inspection.
  • Provides solutions to technical problems and assists on special projects.
  • Maintains lot traceability, log sheets, and good housekeeping practices at all times.
  • Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.

What does it take to be successful?

  • High school diploma required.
  • Previous experience working in a GMP facility a plus.
  • Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR / 98-282, 93 / 42 / EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.
  • Knowledge of scientific products and services.
  • Conform to all customer requirements for background checks, health and safety issues, security clearance.
  • Exhibits leadership skills and accountability.
  • Fast learner with high attention to detail.
  • Strong communication skills.
  • Excellent Customer Service Skills; display a professional can-do attitude.
  • Perform duties with the highest regard for safety and quality.
  • Ability to understand and follow site protocols, policies and procedures
  • Must be flexible, forward- thinking, motivated, and have the ability to act independently.
  • Basic computer skills including Microsoft Office with proficiency in Word and Excel.
  • Ability to prioritize tasks and meet deadlines.
  • Problem-solving skills.
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