Quality Control Inspector
- Support manufacturing schedules by providing inspections of incoming materials, in-process materials and finished devices as assigned for electromechanical as well as disposable products.
- Complete First Article Inspections including supporting documentation.
- Identify and record any product quality problem(s).
- Review device history records and perform product release.
- Support inspection of engineering prototypes.
- Initiate and/or make suggestions to improve working processes or product (i.e. quality, productivity, etc.)/
- Set up and/or organize QC work stations and receiving quarantine area.
- Review and audit quality records and manufacturing processes including device history records.
Education and Experience
- High school diploma or equivalent work experience.
- 5+ years plus experience in quality control or manufacturing environment; experience in medical device industry or comparable capital equipment industry required.
- Experience in a medical device, FDA QSR regulated industry, including ISO 13485 requirements.
- Experience inspecting disposable product, electro-mechanical assemblies, as well as printed material and labeling.
- Be able to interpret the sampling plans.
- Experience using optical inspection systems.
- Ability to work independently with little supervision.
- Demonstrated proficiency utilizing metrology/inspection tools (i.e., microscope, caliper, micrometer, digital multimeter, hi-pot tester, optical comparator).
- Be detailed oriented.
- Data entry experience is a plus.
- Strong interpersonal and communication skills.
- Strong understanding of Microsoft Office tools, eg, MS Word, Excel, Outlook.