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Job ID :
36589BR
Location :
US - California - Carlsbad
:
Job Description
Job Title: Quality Engineer, Instrument Field Services and Support
Requisition ID: 36589BR


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.
Responsibilities:
  • Leads Quality System implementation project for Instrument Field Services and Support team.
  • Supports day-to-day site-specific quality needs for multiple, moderately complex products or product families. Examples include responding to non-routine quality complaints (e.g. instrument field service and support related failures).
  • Identifies and implements improvements to processes, products, systems, and customer related quality issues.
  • Works with quality teams, and other functions to create and/or modify methods and procedures to ensure appropriate methods and tests are conducted and that instrument field service and support services meet required standards.
  • Collaborates across functions, leveraging others’ quality and technical expertise to troubleshoot problems, interpret data, determine problem solving steps, and create technical reports.
  • May provide guidance or direction to service teams such as assistance with prioritization and investigations.
  • Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions.
  • Evaluates quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements
  • Participates on new product and process design, development and implementation teams
Successful Candidate will have:
  • Excellent written and verbal communication skills. Capability to design and draft training materials, document processes and effectively communicate across diverse teams within the Quality and Services and Support organizations
  • Proven capabilities to project manage Quality System implementations
  • Ability to work independently, be self-starting and proactive with identifying opportunities for improvement
Minimum Qualifications:
  • Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
  • Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project)
  • Site specific software programs (change control notification program, CAPA, etc.).
  • Bachelor’s degree in biotech, science or engineering from accredited college/university.
  • Three to Five years of experience
Preferred Qualifications:
  • Medical Device or Pharmaceutical Regulatory Affairs experience is highly desirable
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.


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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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