Quality Assurance Specialist

1 month ago

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

We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific.

Key Responsibilities
  • Collaborate with cross-functional teams to troubleshoot problems, interpret data, and determine next steps.
  • Ensure compliance with site procedures, regulatory requirements, and ISO 13485 standards.
  • Plan and conduct internal and supplier audits, and manage the internal audit schedule.
  • Manage environmental programs at the site, ensuring adherence to regulatory requirements.
  • Facilitate root cause and risk analyses to identify and mitigate potential issues.
  • Serve as Quality Owner for corrective and preventive actions, ensuring timely and effective resolution.
  • Lead quality and operational projects, driving process improvements and enhancements.
  • Undertake delegated tasks from the Manager as required.
Requirements
  • Bachelor's or Master's degree in a relevant field, such as biology, chemistry, biochemistry, or chemical engineering.
  • Solid knowledge of GMP and/or ISO 13485 standards.
  • Experience as an internal or external auditor, with certification as an auditor being an advantage.
  • Experience in Change Control, CAPA, and Root Cause Analysis.
  • Experience in the Medical Device or Pharma industry, or similar experience from other industries such as food, chemical, or Oil & Gas.
  • Fluency in Norwegian or other Scandinavian language, in addition to English.
Personal Attributes

We are looking for a solution-oriented, analytical, and resourceful individual with a strong desire for continuous improvement. The ideal candidate will have excellent communication and interpersonal skills, with the ability to work well with everyone at all levels in-house. A proactive and independent individual who can 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, with opportunities for growth and development.
  • Great benefits and company socials.

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

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