Quality Assurance Specialist

4 weeks ago

Lillestrøm, Viken, Norway Thermo Fisher Scientific Full time
Job Title: Sr Quality Specialist

Join our team of dedicated professionals at Thermo Fisher Scientific as a Sr Quality Specialist. In this role, you will be responsible for ensuring compliance with site procedures, regulatory requirements, and ISO 13485 standards.

Key Responsibilities:
  • Collaborate with cross-functional teams to troubleshoot problems, interpret data, and determine next steps.
  • Plan and conduct internal and supplier audits, and manage the internal audit schedule.
  • Manage environmental programs at the site.
  • Facilitate root cause and risk analyses.
  • Serve as Quality Owner for corrective/preventive actions.
  • Lead 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, with certification as an auditor an advantage.
  • Experience in Change Control, CAPA/Root Cause Analyses, and Medical Device or Pharma industry.
  • Fluency in Norwegian or other Scandinavian language in addition to English.
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 are able to create an environment where individuals feel valued and motivated.

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

We look forward to receiving your application, comprising a cover letter alongside your CV, both submitted in English.

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