Risk Management Specialist

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SummaryVarex Imaging is looking for a Risk Management specialist for the following functions:
 Responsible for regular and timely updates of the Risk Management file
 Responsible in coordinating with cross-functional team and subject-matter experts at the Varex Corporate Office in Salt Lake City, United States for the implementations of mitigations and corrective actions to reduce or eliminate user and product safety risk.
 Responsible in monitoring and conducting vigilance activities from all regulatory body and jurisdictions worldwide
 Conduct vigilance and post market surveillance activities

Job Description

Risk Management Specialist

Varex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. With a 65+ year history of successful innovation, you will find our components in countless medical, industrial, and security imaging applications worldwide. Our mission states that through the talent of our people and vision of customers, we help improve and save lives throughout the world by making the invisible visible. Our values of Excellence, People, Innovation, and Customer are foundational to our success in upholding our mission.  We cannot make the invisible visible and uphold our mission without our EPIC employees, who deliver cutting edge technology globally, consistently pursue the highest quality standards, engage in a diverse and ethical workforce, inspire innovation, and showcase a customer mindset. We strive every day to make a difference in the lives of both our customers and theirs.

Description of Group/Department

Candidate will be part of the Field Assurance and Complaint Handling Unit.  Our team helps reduce the number of returns and increase customer satisfaction by addressing complaints in a timely manner and a quality mindset in all things we do.  In addition, the team reviews field signals for potential product risk or new failure modes with the goal of keeping all customers and users safe to meet regulatory compliance.  There are always interesting and challenging opportunities in production and engineering that require us to work together as a team and leverage each other’s experience. We are a tight knit group that shares the  hard work and have fun while we perform our duties to help make our products better in line with our Mission: “…Making the Invisible, Visible!

Essential Duties and Responsibilities:

• Maintain Risk Management Tool with new potential hazards, mitigation, risk rating etc.

• Conduct Risk Review meeting with Design, Engineering, QA
• Run database searches to look for incidents or reported events concerning Varex or similar products, or where Varex product maybe involved.
• Use risk-based approach in reviewing critical changes for  ECNs (Eng. Change Notice)
• Assist RAQA team during audits.
• Conduct regular post market surveillance activities

Required Knowledge, Skills, And Abilities:

• Bachelor of Science degree in Mechanical or Biomedical Eng.
• Python programming skills and/or Excel macro programming is a plus
• Job requires candidate to be available from 8:00AM to -12:00 Noon Mountain Std Time or 9:00PM-1:00AM India Standard time (note US time changes during DST month) in order to interface and engage better with the U.S. team.
• Critical thinker with attention to detail, ability to think 2,3,4 steps ahead.
• Quality mindset that is open for multiple solution pathways in problem solving
• Able to read and interpret technical drawings and specifications.
• Possess strong analytical skills in Data Analysis and Statistics.
• Familiar with MS Office software, skills in advance Excel function a plus.
• Highly motivated and self-driven
• Strong interpersonal and communication skills (oral and written)
• Can work under pressure and conflicting priorities

Required Certifications and Training

• Obtains and completes LMS training plan specific to assigned responsibility.

Experience Level with Business Tools

• Proficient in utilizing business tools such as:  E-mail, Microsoft Word, Excel, and PowerPoint. 
• Experience with SAP or equivalent ERP product and productivity software desired.

LEVEL DESCRIPTION

Knowledge

• Learns to use professional concepts.  Applies company policies and procedures to resolve routine issues

Job Complexity

• Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Interaction

• Builds stable working relationships internally.

Supervision

• Normally receives detailed instructions on work.

Ability to Travel

• Travel required as per the business needs.

Time Type:

Full time

Job Type:

Regular

Work Shift:

N/A

Pay Rate Type:

Salary

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.