Quality Support 1

Duration: 7 months

This position has responsibility for administration and processing of paper and soft QMS records supporting improvement projects for the Molecular DX Business. This position is located in Berkeley, CA and reports to the Sr. Manager of Quality. 

Required Knowledge/Skills, Education, and Experience 
• Ability to primarily work independently. 
• Typically requires 1-2 years successful experience in a document administration role, preferably in a medical device industry. 
• Candidate must be detail oriented, to review documents with specific requirements in mind and ensure the posting process is completed. 
• Ability to prioritize and organize workload to meet business needs and turnaround time requirements. 
• Customer orientation – works in a supporting role and communicates with cross functional teams and partners at all levels in the organization. 
• Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents. 
• Experience working on a regulated Medical Device, IVDD or Pharma environment 
• Strong abilities in Microsoft Office applications specifically excel. 
• Experience in SharePoint 

Preferred Knowledge/Skills, Education, and Experience 

• An associate in related field is preferred. 
• Knowledge of the Quality System Regulations (in particular, overall Quality management system, Document Management and Record retention requirements) 
Key Competencies: 
• Planning and organizing 
• Communications skills 
• Critical thinking and interpretation 
• Adaptability 
• Records management (prefer in Medical device – ISO 13485/CFR 820) and workflow flexibility

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