Product Surveillance Specialist (Contract)

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 makes treatment 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.

Essential Duties and Responsibilities:

• 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.

Qualificiations:

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.

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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.