Job Description
Job Title:Quality Assurance Management Services Manager
Job ID:269288
Location: US-Virginia-Ashburn
Full/Part Time: Full-Time
Regular/Temporary:Regular
Day to Day Work
Responsibilities include:
* Develop and deploy procedures for implementing and documenting corrective and preventive actions
* Develop and deploy procedures for implementing and documenting regulated problem management
* Perform Regulated problem management
* Determine and implement immediate actions
* Investigate the cause of problems related to processes, procedures and the quality system
* Perform root cause analysis to identify root cause of problems related to processes, procedures and the quality system
* Evaluate problem management metrics for recurring quality problems
* Apply appropriate statistical methodology to detect recurring quality problems
* Analyze processes, work operations, quality audit reports, quality records and other sources to identify existing and potential causes of non-conforming products
* Manage problem management activities and timelines
* Define and implement quality metrics for managing and providing service to IT Outsourcing clients as a vendor.
* Establish a Medical Device Complaint System to support client requirements and
Technical & Behavioral Skills
Certification:
* ITILv3 Foundations
Experience:
* 3+ years of experience with design/development of regulated problem management
* Knowledge and understanding of Title 21 Code of Federal Regulations for medical devices and blood products including but not limited to 21 CFR 820, 21 CFR 210, 21 CFR 211 and 21 CFR 606
* Understanding of ISO 9001:2008
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