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Post Market Surveillance Analyst- Remote US

Company: Varian
Location: San Jose
Posted on: January 16, 2022

Job Description:

Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's 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 is part of the post market surveillance (PMS) team supporting Varian's ROS and MDO product lines. In this role, you will have the opportunity working with various business functions and leading cross-functional efforts in ensuring the PMS process compliant.

The Post Market Surveillance Analyst is part of the post market surveillance (PMS) team supporting Varian's ROS and MDO product lines. In this key role, the Post Market Surveillance Analyst will have the opportunity working with various business functions and leading cross-functional efforts in ensuring the PMS process compliant.

Responsibilities

_Implements and maintains post market product surveillance established procedures.

_Creates and maintains the product PMS plan.

_Integrates data from multiple sources to produce post market reports.

_Monitors product post market signals/trend. Utilizes statistical analysis techniques to investigate field failures and gain insight into product performance.

_Reviews, analyzes, interprets, and summarizes post market data; draw conclusions and make appropriate recommendations and decisions.

_Establishes and maintains report forms and formats, information dashboards, data generators, and other business information portals or resources.

_Supports cross functional teams and stakeholder groups with ad-hoc data analysis and other product safety focused deliverables.

_Remains informed of new or revised PMS regulations/guidelines and assess process impact.

_Supports vigilance reporting related to product safety and complaints.

_Supports escalated complaint handling process.

Requirements

_BS/MS degree in Engineering, Math, Statistics, science-related field, or equivalent technical experience.

_3+ years of direct work experience in medical device quality functions, CAPA, complaint handling, or field action is preferred.

_Knowledge of FDA's 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR.

_Intermediate to advanced Excel and Minitab skills.

_Familiar with database application like QlikView, Unity, Splunk, SAP, and MES.

_Proficient in using business tools like MS Office, Teams, Outlook, and Project.

_Strong organizational, time management, and influence skills.

_Proficient written and communication skills with ability to lead meetings.

_Motivated to learn and pick-up new concepts quickly.

_Ability to thrive in a fast-paced, dynamic, and often ambiguous work environment.

To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations.

To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations .

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.

#TogetherWeFight

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Keywords: Varian, San Jose , Post Market Surveillance Analyst- Remote US, Professions , San Jose, California

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