Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryAs directed by the Manager/ Sr. Manager Quality, the Quality System Specialist II (QSSII) is accountable for review of complaints for MDR
reportability, completion of Medical Device Reports into the eMDR system and other projects as assigned.
- Maintains and resolves assigned tasks through the complaint database.
- Performs tasks, of moderate complexity, within planned schedules and timelines, supporting audits, participating on project
- teams, ensuring documentation compliance, handling processes and assigned tasks related to customer complaints and MDR’s
- Follows applicable Company / Unit procedures and may revise policies and procedures when asked upon.
- Develops solutions to assigned activities of limited scope (e.g. Document change, Complaint file entry, MDR documentation, etc.).
- Prepares reports and summaries as directed, including quantitative and qualitative analysis.
- Completes MDR DT’s.
- Completes MDR’s into the eMDR system.
- Knowledge of decisions regarding reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
- Closely monitors quality, completeness and timeliness of MDR DT completion. Reviews, tracks, trends, analyzes and reports on MDR data
- Minimum Associates Degree in Nursing or Sciences.
- Understanding of quality science, clinical usage of devices, knowledge of quality systems, and strong performance management skills.
- Excellent communication skills
- Excellent team and interpersonal skills.
- Detail orientated.
Additional and Preferred Skills and Qualifications
- Bachelors degree in Science, Nursing, Mathematics or Engineering preferred..
- Knowledge in regulations for Medical Device Reporting (MDR) preferred.
- Duties are very complex in nature and pertain to the overall interaction of many Quality Systems
- Must be able to multitask and prioritize effectively to meet business goals and departmental objectives
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race,
color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional
or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA UT - Sandy
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory