Quality System Specialist I

Qualifications

Preferred Bachelor’s degree in Biological or Life Sciences, however associates degree or applicable experience will be considered.

Responsibilities

• Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints relative to MDR reporting.
• Monitor and communicate significant complaint trends, adverse events and other pertinent reports/ information relaative to a specific MDR.
• Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns as needed.
• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
• Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.
• Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles.
• Other duties as assigned.