Senior Quality Control Inspector

Autonomous Medical Devices Incorporated (AMDI)

AMDI is a California-based company employing a world class team of engineers, scientists, clinicians, manufacturing and quality / regulatory experts dedicated to the development and manufacture of best in class diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA where it manufactures the Fast PCR Mini Respiratory Panel in an ISO:13485 / MDSAP certified 110,000 square foot facility.

Are you a detail-driven professional with a passion for quality? We are seeking a Senior Quality Inspector to join our team! As a key member of the Quality team, you will play a critical role in ensuring that our products meet the highest standards of safety, effectiveness, and compliance. The Senior QC Inspector will be a hands on individual that will perform inspection and testing of incoming materials, in-process samples and finished products to ensure the materials and products conform to specifications and requirements.

Communicate with team and management promptly on quality related issues. Initiate Non-conformance Report (NCR) and assist with the calibration and preventive maintenance program of equipment/instruments.

This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred.

• Perform visual, dimensional, and functional inspections and/or testing across all components, subassemblies and finished medical device products using all applicable tools and equipment to ensure conformance with design specifications
• Archiving receiving inspection and other QC records in Oracle PLM
• Perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
• Ensuring all necessary samples are pulled and tested per procedures requirement
• Determine acceptability and/or identify defective raw materials and finished products following established procedures and specifications
• Provide immediate feedback to production line and immediate leadership on all quality related problems
• Support the calibration and preventive maintenance program
• Initiate Non-conformance Report (NCR) as needed
• Additional projects and/or duties as assigned

• High school Diploma or equivalent required. Associate degree or higher preferred
• A minimum of 8 years of inspection and testing experience in GMP environment, preferably in the medical device or pharmaceutical industries, is required
• Proficient in a wide range of dimensional inspection techniques/equipment (caliper, micrometer, drop indicator, pin gauge, CMM, Keyence, optical inspection system) with good hand eye coordination and high manual dexterity
• Contribute to and support the development of accurate and rugged inspection procedures
• Able to clearly describe and convey nonconformance issues
• Experienced in a fast paced environment and able to balance and prioritize workload to support production schedule
• Ability to train others in methodology and procedures
• Ability to serve as a role model to other workers/colleagues in proper execution of day-to-day inspection duties as well as a guide in the understanding of operations and quality standards
• Proficient computer skills in Microsoft Office Excel and Word, manufacturing software, QMS software, etc
• Must be hands on and ability to as needed perform physical work pertaining to inspection
• Tech-savvy and able to learn new software quickly
• Ability to gets things done without perfect resources, is innovative, and works with a sense of urgency
• Ability to be flexible and willing to do what it takes to support company and department goals
• Results oriented – drives progress & excellence
• Ability to work independently with minimal supervision
• Effective interpersonal and communication skills
• Well organized and attentive to details
• Contributes to a collaborative and inclusive work environment
• An individual with high standards, takes ownership, and is invested in the outcome, is preferred
• Ability to be proactively helps others,…