Posted in Other 8 days ago.
Together, we can beat cancer.
At Varian, we bring together the worlds' best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you.
This position will be part of a small team supporting complaints and post market product surveillance for Varian's VIS product lines. This includes a line of implantable Microspheres and Ablation products.This will include Project Managing the Escalated Complaint Team(s) (ECT) creation and management of Post Market Surveillance Plans, Periodic Safety Update Reports (PSUR) and Post Market Data trending reporting. This role requires working with and through appropriate in-country and out-of-country corporate and business operational functions, leading cross-functional efforts to ensure the Company's PMS processes
Manages the escalated complaint process for VIS products and is responsible for all documentation of the product complaint, planning of required activities and managing the timeline. Provides direction and feedback to ECT members. Oversees Technical Investigations - determines if they are accurate, complete root cause analysis & appropriate solutions to address the issue(s).Ensures any complaints which pose potential risk and/or deficiencies are evaluated for corrective action and potential field correction Ensures that established Complaint Handling, Post Market Risk and CAPA (NC) procedures are followed. Identifies trends in complaints, reviews failure modes of products, root cause assessments, and recommends corrective actions when necessary. Provides timely Adverse Event reporting. Provides metrics/analysis as requested to management. Prepare responses to Regulatory Authorities. Oversees post market Risk Analysis process and provides feedback - determines if the risk is properly identified/mapped.
Post Market Surveillance
Prepares and maintains PMS Plans Prepares and maintains PMR and PSURs. Collects and performs trend analysis and evaluations of information for PMS reporting. Utilize Minitab to perform statistical analysis to investigate field failures and gain insight into product performance. Monitor changes in post market quality signals, propose and/or lead appropriate next steps and document appropriately;
Extracts monthly post market quality data from databases and create presentations summarizing major product quality issues and complaint trends;
Support cross functional teams and stakeholder groups on ad-hoc data analysis, data mining, data queries in support of product performance, regulatory, compliance and other product and safety focused deliverables/requirements
Bachelors degree (or equivalent experience) and5 years of related experience
Knowledge of FDA's 21 CFR part 820 (QSR), 21 CFR 803 (MDR), ISO 13485:2016, ISO 14971, MDD, EUMDR Direct experience handling complaints in the medical device industry
Experience with implantable sterile medical devices.
Strong organizational and time management skills.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.
Strong influence management skills.
intermediate to Advanced Minitab skills.
Fighting cancer calls for big ideas.
We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.