at Agiliti, Inc. in Eden Prairie, Minnesota, United States
Job Description
Job Description:
The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives.
PRIMARY DUTIES AND RESPONSIBILITIES
Quality Systems Specialist: Level 3
Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
Support post market surveillance including recalls, equipment incidents, customer feedback, advisory notices and complaints.
Assist in internal and external ISO 13485 audits of QMS
Guide, supervise, and/or coach other Quality Systems Specialists
Strong influence in corporate setting; sought out to lead projects of large scale with cross-functional teams
Create Quality practices and standard work based on understanding of users, systems, and applicability
Active in professional Quality organizations or other means by which to maintain current on Quality trends
Analyze usability feedback and complaint trending and make recommendations and/or changes
Create and maintain Quality project schedules and delivery milestones for completion
REQUIRED EXPERIENCE
Quality Systems Specialist: Level 3
Bachelor's degree in life sciences, engineering, or technical communications strongly preferred
Minimum 5 - 8 years Quality experience OR advanced degree with 3 - 5 years of applicable experience
Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices
Familiarity with managing 21 CFR Part 806, Medical Device; Reports of Corrections and Removals
Experience guiding and coaching others
3+ years of experience leading Quality projects
Experience improving and maintaining an effective Quality Management System
REQUIRED SKILLS & ABILITIES
Proficient computer skills in MS Office Suite and in an electronic ERP system
Ability to sit, stand, lift, bend and stoop numerous times throughout the day
Flexibility in work schedule in order to meet department needs; may require up to 10% travel
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy, and all other documented quality processes and procedures
For those individuals that supervise others, the following statements are applicable:
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality Management System compliance and adherence to the Quality Policy
Establishes and promotes a work environment that supports the Quality Management System and Quality Policy
These job descriptions in no way state or imply that these are the only duties to be performed by the employee in one of these positions. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.
It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws.In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports. Affirmative Action Policy Statements
You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination.
Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.
Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.
If you require assistance with your application, please... For full info follow application link.
We are proud to be an EEO/AA Employer/Vet/Disabled. We maintain a drug-free workplace and perform pre-employment background and drug testing.
