Quality Assurance Specialist

2 weeks ago

Lillestrøm, Viken, Norway Thermo Fisher Scientific Full time
Job Description

As a Sr Quality Specialist at Thermo Fisher Scientific, you will play a key role in ensuring the quality of our products and services. Your primary responsibilities will include collaborating with cross-functional teams to troubleshoot problems, interpreting data, and creating technical reports. You will also be responsible for ensuring compliance with site procedures, regulatory requirements, and ISO 13485 standards.

Key Responsibilities
  • Collaborate with cross-functional teams to troubleshoot problems and interpret data
  • Ensure compliance with site procedures, regulatory requirements, and ISO 13485 standards
  • Plan and conduct internal and supplier audits
  • Manage the internal audit schedule
  • Facilitate root cause and risk analyses
  • Serve as Quality Owner for corrective/preventive actions
  • Be Quality Lead in Quality and Operational Projects
Requirements
  • Bachelor's degree or Master's degree in biology, chemistry, biochemistry, chemical engineering, or a related field
  • Solid knowledge of GMP and/or ISO 13485
  • Experience as an internal or external auditor
  • Experience in Change Control
  • Experience in CAPA/Root Cause Analyses
  • Experience in Medical Device or Pharma industry is an advantage
Personal Attributes

You are a solution-oriented, analytical, and resourceful individual with a strong desire for continuous improvement. You have excellent communication and interpersonal skills, and you are able to work well with everyone at all levels in-house. You create an environment where individuals feel valued and motivated.

What We Offer
  • A large QA team of dedicated and helpful colleagues to spar with
  • Great culture of collaboration between Quality and Operations
  • Senior role within the team and an opportunity to take on more responsibilities
  • Great benefits and company socials

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