Quality Systems Specialist I
Quality Systems Specialist I
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$ 52844 - 84572
1 Vacancy
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 1
- Participate in all Quality Management System (QMS) activities including document change management records management training/competency nonconforming 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
Quality Systems Specialist: Level 1
- Bachelors degree in life sciences engineering or technical communications strongly preferred
- 0 3 years Quality or other applicable experience
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
This job description in no way states or implies these are the only duties to be performed by the employee in this positions. It is not intended to give all details or a stepbystep 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 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 Agilitis 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 COVID19 vaccination.
Agiliti offers a robust suite of benefits for regular fulltime nonunion employees including: health insurance options for Medical Dental & Vision plans Short and LongTerm 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
Primary Job Location:
Corporate MNAdditional Locations (if applicable):
Job Title:
Quality Systems Specialist ICompany:
Agiliti
Location City:
Eden PrairieLocation State:
MinnesotaPay Range for All Locations Listed:
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 jobrelated knowledge skills and related factors. Dependent on the position offered shortterm and/or longterm incentives may be provided as part of the compensation. Applicants should apply via Agilitis internal or external career site.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
