Quality System Specialist

Qualifications

Preferred bachelor’s degree in Biological or Life Sciences, however associate’s degree with applicable experience will be considered. Under the direction of the Sr. Manager Quality Assurance, the Staff Quality System Specialist II will be responsible for processing customer complaints specifically Medical Device Reports (MDR’s) and Adverse Drug Events (ADE's), including maintenance of complaint files, responses to customers and complaint reports. Provide guidance and education regarding processing of MDR’s and ADE's.

Sandy, UT
12+ Months contract
8 AM to 5 PM
Weekly 42.50 hours (Mon–Fri)

Under the direction of the Sr. Manager Quality Assurance the Staff Quality System Specialist II will be responsible for processing customer complaints specifically Medical Device Reports (MDR’s) and Adverse Drug Events (ADE's), including maintenance of complaint files, responses to customers and complaint reports. Provide guidance and education regarding processing of MDR’s and ADE's.

• Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints relative to MDR reporting.
• Provide guidance, final review and approval of generated MDR reports in accordance with BD procedures and FDA regulations.
• Contribute to the business‑wide quality strategy and quality objectives.
• Maintain systems to monitor and facilitate the timely MDR investigations and close out of open complaints.
• Monitor and communicate significant complaint trends, adverse events and other pertinent reports/ information relative to a specific MDR.
• Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.
• Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns.
• Assist in maintaining customer relations via teleconferences, written correspondence, on‑site visits, conventions and meetings.
• 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.
• Provide education:
  Offers ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment of MDR's.
• Complies with all local client quality policies/procedures/practices through consistent application of sound Quality Assurance principles.
• Other duties as assigned.