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Lead Quality Assurance Inspector
2 months ago
We are seeking a highly skilled and experienced Quality Assurance Lead to join our team at Argen Corporation. As a Quality Assurance Lead, you will be responsible for coordinating the Quality Assurance Inspectors to ensure the quality of our products and services.
Key Responsibilities- Coordinate the Quality Assurance Inspectors to inspect incoming materials, work in-process, and finished goods to ensure conformance to ISO 13485:2016, FDA regulated standards, customer specifications, and Argen requirements.
- Ensure the Quality Inspection area is running efficiently and make on-the-spot personnel adjustments to keep processes on time.
- Communicate clear instructions to team members and ensure safety guidelines are followed.
- Facilitate team participation and act as a liaison between inspectors and the Supervisor.
- Assist the Supervisor in conducting and documenting training and ensure compliance to all applicable regulations.
- Ensure completeness and accuracy of quality inspection documentation and 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.
- 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 maintain proper inspection and test records.
- Assure that non-conforming material has been properly identified and 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 and maintain lot traceability, log sheets, and good housekeeping practices at all times.
- Maintain 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, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC, 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.
- Health Plans
- Dental Plans
- Vision Plan
- 401k with Employer Match
- Paid Time Off and Paid Holidays
- Employee Events
- Wellness Programs
- Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more
