Quality Systems Specialist I

About the position

The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives. This position involves participating in all Quality Management System (QMS) activities, supporting post market surveillance, authoring QMS documents, and providing Quality support to field offices. The role also includes assisting in internal and external ISO 13485 audits and monitoring governmental standards and guidelines.

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

Requirements

• Bachelor's degree in life sciences, engineering, or technical communications strongly preferred
• 0 - 3 years Quality or other applicable experience

Benefits

• 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
• Wellness programs