Job Title:Sr. Quality System Specialist - Bloomington, MN
Let Wright be your "Destination Workplace"
This position is primarily responsible for managing the execution of Management Controls, Data Governance Systems and Quality System (QS) subsystem(s) (such as Corrective and Preventive Action (CAPA), Nonconforming Events (NCE), Complaints, Field Actions, Facility Licensing and Registrations, etc.), which is comprised primarily of the Management Review Process, Quality System Metrics and management/training of the QS subsystem. This position will also be responsible for participating in and sometimes leading strategic Quality and Regulatory Assurance projects as assigned by senior Quality leadership.
Manage processes for Quality data collection and prepare data for presentation in forums such as Management Review and QS subsystem meetings
Be involved in the design or modification of Quality Systems processes
Own, execute, and administer site level trending in accordance to established procedures
Lead or participate in training activities related to the QS subsystem
Other projects as assigned by Quality management
What It Takes:
EDUCATION AND EXPERIENCE
4-year degree preferred; 2-year degree required
4+ years relevant industry experience required
Preferred, not required Certified Tissue Bank Specialist through the American Association of Tissue Banks (CTBS)
Preferred, not required Certified Quality Auditor (CQA) through the American Society for Quality (ASQ)
Combination of education and experience may be acceptable
Planning and Organizing
Critical Thinking and Judgement
Ability to effectively interface and communicate with senior management, senior technical operators/quality management, compliance consultants and regulatory authorities
Ability to influence and drive change
Establishing and maintaining cooperative working relationships with others
Communicating clearly and concisely, both orally and in writing
Handling multiple projects, duties and assignments
Must be proficient with MS Office
Will You Join Us?