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Job ID :
49895BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.


Position Summary:

The Sr. Quality Specialist provides oversight and is a subject matter expertise in complaint handling, medical device reporting, and vigilance reporting in accordance with corporate procedures, and current US FDA and international regulations.


Key Responsibilities:

  • Review, evaluate, and investigate product complaints relative to the identity, quality, safety, and effectiveness of medical products.
  • Identify, generate and publish metrics and reports related to the Complaint Handling, MDR and Vigilance reporting issues.
  • Follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information.
  • Support complaint handling in internal and external audits and inspections.Ensure complaint investigations are adequate, accurate, detailed and timely.
  • Analyze events reported from multiple inputs to determine complaint status and regulatory reporting.
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
  • Analyze and report data using spreadsheets, graphs, and databases.
  • Elevate issues to management as appropriate.
  • Drive continuous improvement of the Quality System.
  • Perform other duties as required


Minimum Requirements/Qualifications:

  • Bachelors’ degree (plus 3-5 years relevant experience) or an Associate’s degree (plus 5 to 8 years relevant experience) in clinical/medical discipline, engineering or science.
  • 3 - 5 years related experience in post-market vigilance/surveillance/complaints with medical devices.
  • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.).
  • Medical device experience is a must.
  • CAPA, and MDR reporting experience required.
  • Regulatory and Quality Management knowledge and skills.
  • Must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.
  • Previous experience in legal, technical or medically related area preferred.
  • Must have demonstrated ability to think strategically.
  • Demonstrated ability to manage multiple activities and tasks.
  • Demonstrated use of quality tools methodologies, and strong computer skills.

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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