Randstad Quality Control Clerk II in Bothell, Washington
Quality Control Clerk II
US$ 15 - US$ 16 per hour
Friday, October 7, 2016
Temp to Perm
Randstad USA Manufacturing & Logistics
-Completes tasks related to record completion validation. Reviews information provided when a customer alleges a malfunction/defect or problem with the field performance of our medical devices.
-Ensures completion of the applicable 11 safety questions and follows up if required to ensure a complete record.
-Generating actionable quality data for product quality trends and improvement.
-Learns basic knowledge of products, how each system functions, tools and processes.
-Maintains confidentiality of all service records and pertinent information.
-Takes ownership of complaints/potential complaints and works on resolution with the BIU within the appropriate time frames.
-Understands the service delivery process and FDA regulations such as 820.200, 820.198.
-Develops a clear understanding of the CAPA process and assistance in the handling and tracking of CAPAs
- Attention to detail is a MUST as there will be a lot of data entry.
Working hours: Monday-Friday: 7am-4pm
-A BS/BA or equivalent experience in business preferred.
-At least 2 to 4 years' experience in an administrative position with experience in a similar documentation/data driven position.
-Intermediate skills in using MS Windows and Office (e.g., Word, Excel). EXCEL skills are very important
-Familiar with FDA regulations including FDA CFR: 820.803, 820.100 and 820.198, and 820.200.
-Well versed in Q&R medical device terminology.
-Work well within a team environment to accomplish departmental goals.
-Must be willing to submit to background and drug screening.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.