Lead Quality Assurance Inspector

Ignite Human Capital • San Diego, CA

85d

About The Position

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 ensure the Quality Inspection area is running efficiently, make on-the-spot personnel adjustments to keep processes on time, and communicate all adjustments to the Supervisor. They will communicate clear instructions to team members, ensure safety guidelines are followed, facilitate team participation, and act as a liaison between inspectors and the Supervisor. Additionally, they will assist the Supervisor to conduct and document training, ensure compliance to all applicable regulations to FDA, ISO, MDSAP, OSHA, etc., and ensure completeness and accuracy of quality inspection documentation. The candidate will assist inspectors by answering questions and demonstrating inspection processes, confirm all Quality Inspectors are up to date on their training requirements in Vivaldi, and reinforce proper adherence to required Personal Protective Equipment (PPE) for the area. They will utilize microscope, digital calipers, micrometer, optical comparator, vision measurement system, and other related equipment with optimal accuracy, provide in-process/final inspection and testing as required, and provide inspection of outside processing (receiving inspection). The candidate will maintain proper inspection and test records, assure that non-conforming material has been properly identified, advise the responsible production personnel of the acceptability of products or materials based on results of testing and/or inspection, provide solutions to technical problems, and assist on special projects. They will maintain lot traceability, log sheets, and good housekeeping practices at all times, and maintain a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.

Requirements

• 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.

Responsibilities

• Ensures Quality Inspection area is running efficiently.
• Makes on-the-spot personnel adjustments to keep processes on time, 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 This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 11-50 employees