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Sr. Quality Technician

1 month ago

Santa Clara, United States KYYBA Full time
Job DescriptionJob Description

Sr. Quality Technician

Santa Clara, CA

12+ months Contract

 

Responsibilities:

·        Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions

·        Responsible for performing in-process and final components, subassembly and product inspection.

·        Measure component dimensions per requirements or inspection plans.

·        Records inspection and test data as prescribed by written instructions and procedures.

·        Understand the capability of measuring tools. Utilize small hand-tools, calibrated instruments, measuring equipment, microscopes and test fixtures

·        Understand material product specifications, engineering drawings and the requirements of the components and parts.

·        Document non-conformance report once parts fail specifications or requirements.

·        Recommend improvements to the production process to ensure quality control

·        Responsible for completing documentation in a timely manner and in accordance with business standards;

·        Foster the production team about quality control concerns to improve quality of the product.

·        Maintain quality documentation in accordance with SOPs, WIs and GMP (CFRs)

·        Resolve quality-related issues in a timely manner.

·        Perform audits of manufacturing records during assembly to ensure compliance.

·        Perform final manufacturing Device History Record (DHR) and Lot History Record (LHR) review at close of manufacturing process and product release

                                        

Education and  Experience Required

·        High school diploma or equivalent qualification.

·        4+ years’ experience working in manufacturing, or related field.

·        Excellent knowledge of MS Office and Excel.

·        Good math and technical skills.

·        Strong understanding of quality control standards and testing techniques.

·        Positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

·        Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator

·        requirements.

·        Multitasks, prioritizes and meets deadlines in timely manner.

·        Strong organizational and follow-up skills, as well as attention to detail.

·        Ability to maintain regular and predictable attendance.

·        Very high level of attention to detail and accuracy.

·        Excellent verbal and written communication skills.

·        Ability to collaborate effectively.

·        Must be an effective team player with the ability to train other technicians.

 

Preferred

·        3+ years prior medical device experience preferred.

·        Manufacturing Support

·        ISO class A clean environment.

·        4yrs of experience prior medical device exp.

 

Top 3 Skills:

·        Paying attention to detail

·        Accommodate fast changing priority, multi-task

·        Good Team Play able to help each other