Temporary - Quality Control Inspector
- Posted: 12 days ago
Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI’s Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver secure lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its ISO 13485 certified 110,000 square foot facility in Santa Ana, CA.
Summary of Position
The QC Inspector 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. Review device history records to ensure compliance to established procedures and acceptance criteria. Communicate with team and management promptly on quality related issues. Initiate Non-conformance Report (NCR) as needed. Support the calibration and preventive maintenance program.
Essential Duties and Responsibilities
- 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.
- 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.
- Initiate Non-conformance Report (NCR) as needed.
- Review Device History Records (DHRs) and other quality records.
- Support the calibration and preventive maintenance program
- Additional projects and/or duties as assigned
Qualifications required for position
- High school Diploma or equivalent required. Associate degree or higher preferred.
- A minimum of 2 years of inspection and testing experience in GMP environment in medical device or pharmaceutical industries is required.
- Experience with proper usage of all applicable tools and equipment, hand eye coordination, and high manual dexterity.
- Full understanding of applicable inspection procedures, including the ability to contribute to and support the development of procedures.
- Proficient in all inspection techniques for production inspection.
- Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)
- Ability to work in a fast-paced environment and to balance and prioritize workload to support production schedule.
- Ability to program and contribute to the validation of automated test equipment
- Strong communication skills and interpersonal relationship skills, including ability to convey training in methodology and procedures
- Ability to serve as a role model to lower level inspectors in proper execution of day-to-day inspection duties as well as guide other workers/colleagues in understanding operations and quality standards
- Proficient computer skills, including Microsoft office products, manufacturing software, QMS software, etc.
- Strict attention to detail
- Tech-savvy and able to learn new software quickly
Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contract.
Our commitment to an inclusive workplace
We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under federal, state or local law.
Autonomous Medical Devices Incorporated
AddressSanta Ana, CA
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