Clinical Product Surveillance Specialist

General Electric Milwaukee , WI 53201

Posted 2 weeks ago

Clinical Product Surveillance Specialist

  • GE Healthcare

  • Experienced

  • Posted 3/8/2019 3:52:48 AM

  • 3261575

  • Job Function: Quality

  • Business Segment: Healthcare Quality

Location(s): United States; Wisconsin; Milwaukee

Role Summary:

Uses knowledge of clinical workflow and product use in assessing incoming complaints and the hazards they may contain as well as assisting in determining postmarket reportability. Provides guidance to a cross-functional team on clinical scenarios and how to identify potentially hazardous situations in complaints.

Essential Responsibilities:

Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)

Responsible for hazard evaluations

Participate in Risk Assessments

Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products

Follow-up with the end user / customer

Participate in complaint investigations, CAPA and proper complaint closure according to set criteria

Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations

Manage risk by identifying product safety issues; triage complaints for further investigation

Qualifications/Requirements:

Bachelor's degree in medical science, heath sciences or healthcare related field and a minimum of 2 years of clinical experience;

OR high school diploma/equivalency degree plus a minimum of 6 years of clinical experience

Desired Characteristics:

Product-specific knowledge

Registered Nurse or CRNA or Registered Radiologic Technologist

Demonstrated knowledge of 21CFR Part 820

Ability to demonstrate GEHC Growth Values

Understanding of the clinical environment and product work flow

Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment

Ability to work independently & in a team setting

Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).

Excellent interpersonal, organizational, and influencing skills

Familiarity with the application of medical device as it relates to patient safety11. Ability to analyze and process data, and draw the appropriate conclusions12.

Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems13. Ability to analyze and process data, and draw the appropriate conclusions14. Prior experience working with Microsoft Office products15. Working knowledge of GEHC products

About Us:

GE Healthcare provides transformational medical

technologies and services to meet the demand for increased access, enhanced quality and more affordable

healthcare around the world. GE works on things that matter - great people and technologies taking on tough

challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,

biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps

medical professionals deliver great healthcare to their patients.

target="_blank">Learn More About Careers at GE

Learn More About GE

Healthcare

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Locations: United States; Wisconsin; Milwaukee

GE will only employ those who are legally authorized to work in the United States for this opening.



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Clinical Product Surveillance Specialist

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