Lead Quality Assurance Inspector

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.

• 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.

• High school diploma required.
• Previous experience working in a GMP facility a plus.
• Knowledge of cGMP regulations ISO 13485, 21
  
  CFR 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.