- Read and understand dimensional drawings, geometric tolerancing, specifications and instructions on quality requirements for components and raw materials.
- Select representative samples for inspection.
- Dimensionally and visually inspect components and materials with a variety of precision measuring instruments, gauges and other manual inspection/test equipment.
- Dimensionally and visually inspect components with automated equipment and materials with analytical testing procedures.
- Document the approval or rejection of the materials with respect to quality requirements and industry standards and record supplier performance.
- Document and maintain records of inspection and testing, initiate non-conformance reports and track inspection metrics as requested.
- Collaborate with Material Quality and Manufacturing teams to address and resolve quality related issues.
- Collaborate with Material Quality, Manufacturing, and Development teams for the development and qualification of inspection/test methods, tooling/equipment, and new components/materials.
- Perform first article inspections on components and/or fixturing.
- Use basic statistical tools such as statistical process control (SPC) and pareto charting to trend component inspectional results.
- Monitor the equipment to ensure it is safe and well-maintained and notify supervisor or any equipment that doesn't meet requirements.
- High school diploma or equivalent
- 2-year minimum experience in medical device inspection. Vocational or technical education may be used in lieu of experience.
- Demonstrated experience in the use of inspection tools and equipment (e.g. calipers, micrometers, microscopes, DMM, etc.)
- Demonstrated skills and ability to prioritize, execute and report on projects.
- Strong verbal and written communication skills
- Demonstrated attention to detail when generating and reviewing all documentation.
- Ability to work on multiple tasks concurrently with changing priorities.
- Proficient with MS Word and Excel.
- Vocational or technical education or certification
- Geometric tolerancing and blueprint reading
- Associate or Bachelor's degree in a technical or scientific field
- 3 – 5 years' experience in receiving and/or manufacturing quality inspection in the medical device industry
- Demonstrated hands-on capabilities with CMM, OGP, Keyence, etc.
- Knowledge of ISO and FDA Quality System Requirements (e.g., 21 CFR 820 and ISO 13485)
- Experience in material, component, process, and product quality assurance functions
- Experience with engineering tools such as; dFMEA, pFMEA, SPC, Minitab, etc.
- ASQ certifications; CQI, CQT, CQA, etc.
- Ability to lift 50 lbs. and move boxes of components, materials, and equipment.
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Quality Inspector - Golden Valley, United States - Inspire Medical Systems
Description
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team
ABOUT THIS POSITION
This position will support the areas of component inspection, component manufacturing, and supplier quality management. This person will be responsible for receiving inspection, material transactions, and general support for the Material Quality group. This position will work with Material Quality, Operations, Manufacturing and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Required Qualifications
Preferred Qualifications
Physical Requirements
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