Responsibilities: Perform incoming inspection of materials and receiving documentation for conformity to specifications. Support manufacturing operations through timely review of DHR's including release of finished goods. Adhere to good manufacturing practices and good documentation practices. Assist Quality Engineers and manufacturing personnel in the execution of calibration activities including review and retrieval of calibrated equipment for processing. Positive and cooperative communication and collaboration with all levels of employees, contractors and vendors. Assist in both internal and external audit preparation. Participate in NCMRs / CAPA's to better improve company practices and systems. Perform quarterly Air Sampling / Particle Testing in the Clean Room. Other duties as assigned. Requirements: High School Diploma or equivalent is required. Additional training in Quality and/or a focus in medical device preferred. 1-3 years of experience in a Quality role (medical device preferred, other regulated industries considered). Strong working knowledge of Microsoft Word and Excel. Understanding of ISO 13485, ISO 14644, and CFR 21-820. User experience of QMS, PLM and CMMS systems. Organizational skills and attention to detail. Ability to read drawings and prints.
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Job Type
Full-time
Career Level
Entry Level
Industry
Electrical Equipment, Appliance, and Component Manufacturing
Education Level
High school or GED
Number of Employees
1,001-5,000 employees