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Analyst, Product Surveillance
GTT, LLC
- 🇬🇧 United Kingdom | 🇺🇸 United States
- On-site
- 3 hours ago
- Microsoft Office Applications
- Pension
3 hours ago
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The Product Surveillance Analyst supports post-market surveillance activities through the inspection, testing, and evaluation of returned medical devices. This position assists in product complaint investigations by performing laboratory analyses, documenting findings, and supporting the determination of device performance characteristics. The role requires strong attention to detail, adherence to procedures, and accurate documentation within quality system requirements.
Key Responsibilities:
Perform receipt, inspection, and evaluation of returned medical devices associated with customer complaints.
Execute laboratory testing and product performance evaluations according to approved work instructions and procedures.
Document observations, test results, and investigation findings in complaint handling systems and laboratory records.
Support root cause investigations by gathering and analyzing product performance data.
Operate laboratory equipment, tools, and test fixtures safely and effectively.
Review device history information, investigation records, and product specifications as needed to support evaluations.
Maintain compliance with FDA regulations, quality system requirements, and internal procedures.
Collaborate with engineers, analysts, and quality personnel to support complaint investigations and post-market surveillance activities.
Ensure timely completion of assigned investigations while meeting quality and productivity expectations.
Participate in continuous improvement initiatives and support laboratory organization and maintenance activities.
Required Qualifications:
A minimum of 1 year of experience working in a lab environment with hands-on analysis/testing (preferably in the med-device industry but open to others).
Bachelor's degree in a science, engineering, healthcare, or technical field; or equivalent combination of education and relevant experience.
Strong attention to detail and organizational skills.
Ability to follow detailed procedures and accurately document results.
Basic computer skills, including experience with Microsoft Office applications.
Effective written and verbal communication skills.
Preferred Qualifications:
Experience in the medical device, pharmaceutical, biotechnology, or regulated manufacturing industry.
Experience performing laboratory testing, product analysis, troubleshooting, or complaint investigations.
Familiarity with FDA Quality System Regulations (21 CFR Part 820), complaint handling, and post-market surveillance processes.
Experience working with electronic quality management systems such as EPIQ or similar complaint handling databases.
Physical Requirements:
Ability to work in a laboratory environment.
Ability to handle and inspect small medical device components.
Ability to sit, stand, and use laboratory equipment for extended periods.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Client:
For more than 140 years, this global healthcare leader has been at the forefront of medical innovation, developing life-changing technologies, diagnostics, nutritional science, and pharmaceutical products that reach patients in more than 160 countries. The organization's portfolio spans cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation, with recognized brands that millions of people rely on every day.
The company operates across four major business segments: medical devices, nutritional products, diagnostics, and established pharmaceuticals. Its innovations include groundbreaking continuous glucose monitoring technology, rapid diagnostic tests, minimally invasive cardiac devices, and nutritional solutions for patients across all life stages. With global reach and operations in over 160 countries, this is an organization that gives its people the opportunity to make a measurable difference in global health outcomes.
The culture here is grounded in inclusion and innovation. Leadership has built an environment designed to attract and retain diverse talent, supported by employee networks, mentorship, and programs that invest in the next generation of healthcare scientists and engineers. The organization is a certified Great Place to Work, with 80 percent of employees reporting it is a great place to work, well above the national average.
The scale of this company means real resources for development: cross-functional teams, international exposure, and work that connects to a clear and meaningful mission. For professionals who want to contribute to healthcare breakthroughs that touch millions of lives and grow within a company that has built that mission over more than a century, this organization offers a career with genuine purpose and longevity.
Teams here span biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals.
Analyst, Product Surveillance · GTT, LLC