Quality Assurance Inspector
About The Position
This role involves performing various inspection and testing activities to ensure product quality and compliance with regulatory standards. The Quality Assurance Inspector will be responsible for inspecting incoming materials, components, and subassemblies, as well as in-process and finished products. Key responsibilities include conducting First Article Inspections, DHR reviews, and product release activities. The role also requires initiating and managing Non-Conformance Reports (NCRs), quarantining non-conforming products, and maintaining inspection equipment. Adherence to GMP and GDP principles is essential, along with assisting in audit preparations.
Requirements
- Organizational skills and attention to detail.
- Firsthand experience using measuring tools such as but no limited to calipers, micrometers, pin gauges and tensile testers.
- Ability to read and understand drawings.
- Experience working with sampling plan.
- Understanding of ISO 13485, CFR21-820, ISO 146444-1, 2 and 3.
- Able to take direction, ownership, and responsibility for QMS related activities.
- Positive and cooperative communication and collaboration with all levels to employees, contractors and vendors.
- Strong understanding of quality control standards and testing techniques.
- Electronic Quality System experience.
- Proficient with Microsoft Office, Excel, and other electronic systems.
Nice To Haves
- Medical device experience is a plus.
- Experience working a cleanroom is a plus.
Responsibilities
- Perform Inspection of incoming materials, components, and subassemblies
- Complete First Article Inspections upon request.
- Perform In-process and finished (sterile and non-sterile, disposable, and durable) product inspection and testing.
- Perform DHR reviews for subassemblies and finished goods.
- Conduct Product Release activities for all conforming products.
- Initiate NCR records for all non-conforming products, components, and subassemblies.
- Quarantine non-conforming product and participate in the investigation process.
- Maintain Inspection area equipment calibration and PM
- Adhere and promote GMP and GDP principles.
- Assist in external/internal audit preparations.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
