General Electric Company

Sr. Associate Specialist, Product Surveillance, Clinical WHXR

General Electric Company$80K — $95K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree from an accredited university or a high school diploma/GED with 8+ years in Medical Device Manufacturing or clinical experience
  • 2+ years of experience in a clinical setting with X-Ray, Bone Mineral Density, or Mammography devices

Responsibilities

  • Apply clinical knowledge to assess customer complaints and potential risks
  • Evaluate complaints for compliance under 21CFR part 803 (MDR)
  • Communicate complex clinical information in an understandable way
  • Build relationships and support new team members in the Complaint Handling Unit
  • Collaborate with cross-functional teams for thorough complaint investigations
  • Work independently to manage routine responsibilities while knowing when to seek guidance
  • Use analytical thinking and judgment to drive patient safety initiatives
  • Ensure timely complaint handling and contribute to process improvements

Benefits

  • Relocation assistance provided
Full Job Description
Job Description Summary
Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare. Uses in depth clinical knowledge to improve the complaint handling processes and enhance team understanding of products.

Job Description

Roles and Responsibilities
  • Apply clinical product knowledge and product surveillance expertise to review customer complaints, assess potential risk, and determine whether a complaint represents a potentially hazardous situation. Use an understanding of clinical workflows and how products are used in real-world settings to support accurate complaint evaluations and enhance team knowledge.
  • Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)
  • Clearly communicate complex clinical or technical information in a way that is easy for others to understand.
  • Build strong working relationships with colleagues across the Complaint Handling Unit and provide guidance and support to new team members.
  • Collaborate with cross-functional teams including Medical Safety, Engineering, Regulatory Affairs, and hospitals to gather information and support complaint investigations / determine reportability in alignment with regulatory requirements.
  • Work independently on day-to-day responsibilities while following established procedures and knowing when to seek guidance on more complex situations.
  • Use clinical expertise, analytical thinking, and sound professional judgment to investigate issues, solve problems, and make well-supported decisions that impact patient safety. Draw on resources and subject matter experts across the organization as needed.
  • Timely complaint handling, reporting, and training
  • Contribute to improving team processes, projects, and standard ways of working within Product Surveillance

Required Qualifications
  • Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in Medical Device Manufacturing Industry or working in a clinical setting)
  • Minimum 2 years of experience in a clinical setting interfacing with X-Ray, Bone Mineral Density, or Mammography medical devices.


Desired Characteristics
  • Product specific knowledge and/or experience using X-Ray, Mammography, or Bone Mineral Density GEHC manufactured medical devices
  • Prior experience working with Microsoft Office products (particularly Excel)
  • Demonstrated knowledge of 21CFR Part 820
  • Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems, even amongst competing priorities
  • Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
  • Excellent interpersonal, organizational, and influencing skills
  • Ability to analyze and process data, and draw the appropriate conclusions
  • Experience with Lean principles or demonstrated experience implementing process improvements


We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Relocation Assistance Provided: Yes

About General Electric Company

GE Healthcare provides medical technology, intelligent devices, and care solutions. They offer medical imaging, information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies. GE Healthcare's mission is to improve patient care and outcomes by providing innovative healthcare solutions. Their technologies are used in hospitals, clinics, research institutions, and pharmaceutical companies worldwide to diagnose and treat various medical conditions.

General Electric Company Careers

Join the dynamic team at General Electric Company, a global leader in innovation and technology. As one of the most respected companies worldwide, we offer unparalleled job opportunities that propel your career to new heights. Work You’ll Do At General Electric Company, you’ll be part of a diverse team committed to transforming industries and improving lives through leadership in sectors such as aviation, power, renewable energy, and healthcare. Our culture thrives on innovation and leadership, fostering an environment where you can grow professionally and personally. Lead in a Unique Market Position General Electric Company stands at the forefront of digital and industrial transformation. Here, you’ll leverage your skills to solve complex challenges, drive growth, and lead projects that have a global impact. Our commitment to professional development and diversity training ensures that every team member is equipped to lead and innovate. Collaborate with Industry Experts Work alongside a global network of professionals, each bringing a wealth of knowledge and experience to our collaborative projects. General Electric Company’s culture of inclusivity and teamwork makes it a prime environment for networking and personal development. Innovative Work Join us to work on groundbreaking projects that redefine what’s possible. Our teams at General Electric Company are constantly pushing the boundaries of technology and innovation to create solutions that not only meet but exceed the needs of our customers and communities around the world. Be Part of a Great Team At General Electric Company, we understand that our employees are our greatest asset. That’s why we offer competitive benefits, extensive career advancement opportunities, and a supportive environment that values work-life balance. Our commitment to employee growth is reflected in our robust training programs and our focus on internal mobility. Future-Proof Your Career With a career at General Electric Company, your growth is limitless. Through our various training programs, internships, and leadership development initiatives, you can enhance your skills and advance your career in a direction that aligns with your professional and personal aspirations. Explore Job Opportunities and Internships Whether you’re starting your career or looking to make a significant impact in your field, General Electric Company offers a range of positions and employment opportunities that cater to your talents and ambitions. From internships that provide real-world experience to leadership roles that challenge your strategic thinking, there’s a place for you here. Stay Connected Join Our Team Search open positions that match your skills and interests. We are always on the lookout for passionate, curious, and solution-driven team players. Explore the possibilities that await you at General Electric Company. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. At General Electric Company, we’re more than a company—we’re a community. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities available at General Electric Company and become part of a team that’s reshaping the future of technology and industry. Join General Electric Company today and be a part of our journey to build a better world through essential technology and innovative solutions. Your career at General Electric Company awaits—explore, innovate, and lead with us.
Learn more about General Electric Company
Size
168,000 employees
Market Cap
$90.4 billion
Industry
Net Income
$5.7 billion
Founded
1892
5 Year Trend
-9.1%
Revenue
$79.6 billion
NASDAQ

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