Quality Engineer III - Quality Assurance TMO-REQ-011717
Position : Quality Engineer III - Quality Assurance TMO-REQ-011717Location : 3501 Leonard Court, Santa Clara, California 95054)Duration : 4 MonthsJob DescriptionQuality Engineer - Quality AssuranceWhat will you do?• To ensure Product Quality excellence, Oversee the system QA Checkout program beginning with the creation of each customer system Final Checkout Report. Implement required actions or activities related to the process• Inspect Single Use Bioreactors (SUB) and Controller systems ensuring they meet customer and quality requirements, issuing corrective actions and guidance as appropriate within the organization• Use basic engineering knowledge such as voltages (AC/DC, 210/230, etc - which is the right plug); interpret engineering drawings into physical system requirements;• Be able to read/interpret ECO's and BOM's and their impact on the physical system requirements; determine if stated requirements were built correctly.• Interfaces with and provides support to Receiving and Final Inspection personnel as defined by the Quality Manager• Assists in the development, approval, training and maintenance of company specifications and quality assurance procedures• Assist the Quality Manager in collecting and analyzing quality information from various quality systems and assist in the development of reports as needed for senior management review• Develops and maintains specifications, WI & SOP's in area of responsibility. Provide training and oversight to individuals involved in the QA Checkout process• Demonstrated ability to review quality records to verify information is correct and complete and that specifications and/or requirements have been achieved• Identifies and drives continuous quality improvementEducation:Bachelor's degree in Science, Engineering or Technology related field or equivalent.Experience :• Familiarity with inspection procedures• Familiarity working with ERP systems, doc control systems• Familiarity with quality management systems (ISO 13485:2016) and procedure adherence• experience working in manufacturing environment• familiarity with validation protocols• ability to read electrical and mechanical assembly drawings desired• Attention to detail for documentation completion• Demonstrated ability to communicate effectively in all written and verbal contexts• Strong skills in Microsoft office suite and tablet devicesSkill/Experience/EducationMandatory