Quality Systems Specialist I

The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives. Primary Duties and Responsibilities

• 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 recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
• Explain scientific and technical ideas by authoring clear and concise QMS documents, equipment handling procedures, forms, cleaning policies, medical equipment management plans (MEMPs), safety alerts, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
• Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
• Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service or phone support lines
• Assist in internal and external ISO 13485 audits of QMS
• Monitor governmental and associated industry organizations' standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
• Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, and equipment cleaning validations

Required Experience

• Bachelor's degree in life sciences, engineering, or technical communications strongly preferred
• 1 -3 years Quality or other applicable experience preferred

Required Skills and 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

Disclaimer This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all the 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 and the company. 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 contact [email protected]. Primary Job Location: Corporate MN Additional Locations (if applicable): Job Title: Quality Systems Specialist I Company: Agiliti Location City: Eden Prairie Location State: Minnesota Pay Range for All Remote Locations: $42,339.16-$109,933.25 This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. For sales positions, this range combines the base salary and the target incentive pay. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply via Agiliti's internal or external career site. Apply tot his job Apply To this Job