Quality Systems Specialist I

Quality Systems Specialist I

Requirements

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

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.

Preferred Qualifications

No preferred qualifications provided.