Job Description
Job Title:Quality Assurance Management Services Director
Job ID:269289
Location: US-Virginia-Ashburn
Full/Part Time: Full-Time
Regular/Temporary:Regular
Day to Day Work
SUMMARY OF POSITION
Provide Quality Management system deployment and continued enhancement of a compliant Title 21 CFR QMS within the areas of:
o Document control
o Training
o Corrective and Preventive Actions
o Audit
o Regulated Problem Management
o Regulatory Record Management
o Medical Device Complaint Handling
o Validation Quality Assurance
· Develop and deploy risk assessment and risk management
· Perform management responsibilities related to the quality function
· Develop quality systems procedures as required
· Review qualification, verification and validation records as required
· Perform as lead SME in the area of quality management for Biomedical IT quality
management system
POSITION DETAILS:
* Perform as lead Subject Matter Expert (‘SME’) in the area of quality management for Biomedical IT quality management system
* Primary client facing position in areas of regulatory quality as related to IT infrastructure qualifications, validations, and quality problem reporting
* Quality management system management and continued enhancement of a compliant Title 21 CFR QMS with demonstrated experience in the areas of:
* Document control
* Training
* Corrective and Preventive Actions
* Audit
* Regulated Problem Management
* Regulatory Record Management
* Medical Device Complaint Handling
* Validation Quality Assurance
* Manage and perform risk assessment and risk management as related to IT infrastructure and end user services delivery within a Regulated Biomedical environment
* Develop quality systems procedures in the areas of Validation, Quality Planning, Quality Audits and Regulatory Problem Management
* Review qualification, verification and validation records of IT Infrastructure, Biomedical devices and Infrastructure Tools as required
* 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
New Business growth as lead SME for solution offering
Package the services into a Unisys portfolio offering
Establishment and ownership of a new/developing portfolio offering within an IT Outsourcing organization.
Technical & Behavioral Skills
Experience:
* 10+ years of experience with design/development and management of quality assurance and Biomedical IT quality management systems
* Detailed 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
* 5+ years working with FDA Regulatory Compliance
Understanding of ISO 900 1:2008 Regulated Quality Management System (QMS) – experience with quality requirements under Federal Drug Administration (FDA) 21 CFR Part 820
Certifications:
* Certified Manager of Quality/Organization Excellence (CMQ/OE)
* Certified Quality Auditor (CQA) – desired, but not required
* ITILv3 Foundations – desired, but not required
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