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Give hope. Give health. Make your mark in the fight against cancer.
At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives.
But our commitment to innovation offers a truly unique opportunity : the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.
Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.
Job Description
Summary :
The Product Surveillance Specialist effectively implements the complaint handling process and processes complaints in a uniform and timely manner according to regulatory requirements and company practices and policies.
In addition, this position will encompass data mining, statistical analysis, and metric reporting for Product Surveillance.
Completes all required customer complaint related documentation in an accurate, professional, and timely manner.
Evaluates complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting, and any other worldwide regulatory requirements.
Documents and maintains records of all complaint investigations in accordance with 21 CFR
820.198.
Develops, prepares, and analyzes trend reports for complaints; monthly or quarterly as required.
Communicates results with worldwide customer support personnel as well as other internal departments, i.e., Marketing, R&D, Customer Service and Technical Services.
Provides metrics and statistical analysis of data from a large, global complaint pool upon request and at specific intervals when required.
Qualifications : a. Required
a. Required
Bachelor's degree in an engineering or technical field.
Excellent statistical analysis and data mining skills.
Ability to work with a sense of urgency.
Ability to apply critical thinking and problem-solving skills and to work collaboratively to find best solution.
Ability to work in a team environment.
b. Preferred or Desired
Experience in Engineering, Biomedical Engineering, Data Mining, Statistical Analysis and / or Quality Assurance in medical devices, previous Complaint Handling or Technical experience strongly preferred.
Minitab experience
Advanced Excel formula creation for use in data mining and statistical analysis.
SQL programming experience.
LI-BB1
LI-Remote
To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
EEO Statement
At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further.
We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.
Accuray Pay Transparency Statement :
Accuray pay ranges vary based on work location. As a part of the total compensation package, this role may be eligible for the Accuray Bonus Plan or a role-specific commission / bonus, as well as annual refresh stock grants.
Recruiters can share more detail during the hiring process. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, future potential and internal pay parity.
Last updated : 2024-06-10
Full Time
Durable Manufacturing
$56k-66k (estimate)
05/23/2024
09/05/2024
accuray.com
MADISON, WI
500 - 1,000
1999
Public
FRED ROBERTSON
$200M - $500M
Durable Manufacturing
Accuray is a California-based medical device company that manufactures and distributes radiotherapy systems for the treatment of radiation-sensitive diseases.
The job skills required for Surveillance specialist include Customer Service, Problem Solving, Programming, Critical Thinking, etc. Having related job skills and expertise will give you an advantage when applying to be a Surveillance specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Surveillance specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Surveillance specialist positions, which can be used as a reference in future career path planning. As a Surveillance specialist, it can be promoted into senior positions as a Surveillance Supervisor that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Surveillance specialist. You can explore the career advancement for a Surveillance specialist below and select your interested title to get hiring information.