QA/QC Inspector
4550 Norris Canyon Road San Ramon, CA 94583 US
Job Description
*Depending on experience
MAIN RESPONSIBILITIES
• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,
operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors,
and vendors.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),
Environmental Management Systems (EMS), and other regulatory requirements.
EDUCATION
Min -Â High School Diploma / GED
EXPERIENCE
?0-2 year’s experience. Previous experience in Quality performing inspection. Prior medical device component inspection experience preferred. Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing. Training in blueprint reading and experience with inspection sampling techniques. Knowledge of FDA, GMP, ISO 13485. Good communication and computer skills, including Microsoft Word and Excel. ASQ CMI certification preferred. Experience/Background Experience Experience Details Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Must be willing to work overtime as required, including weekends Ability to maintain regular and predictable attendance.
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