Sr. Quality Specialist

3 days ago


Oslo, Oslo County, Norway ThermoFisher Scientific Full time
ThermoFisher Scientific Sr. Quality Specialist in Oslo, Norway

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description:

Thermo Fisher Scientific Norway produces and develops Dynabeads that are used in several billion diagnostic tests worldwide. It is a critical component in one of the most promising cancer treatments and is an industry standard in sample preparation products in the research market. The beads are world-famous for their unique specifications and manufacturing process, which allow use of beads in advanced life science applications.

In Thermo Fisher Scientific, we are working for the right reasons in the right way, and our culture is highly characterized by pride.

We are now looking to find a new colleague to join our Quality Engineering Group in Norway. The Quality Engineering Group is part of the Quality Assurance department and consists of Quality Specialists and Engineers with expertise in Equipment and Process Qualification, CAPA process, Risk Management, Complaint Management Process, and Design Compliance.

Key Responsibilities:

  1. Ensure compliance with quality standards.
  2. Serve as Design Quality and Site Quality Lead for New Product Introduction projects.
  3. Develop and implement Quality and Product Risk Management Plans.
  4. Address and resolve quality issues and customer complaints, collaborating directly with customers and internal experts on complex issues.
  5. Lead teams in conducting risk analyses and developing mitigation strategies.
  6. Use expert knowledge in validation of equipment, instruments, manufacturing processes, cleaning processes, and computer systems to ensure compliance with relevant standards and guidelines.
  7. Collaborate with other departments to investigate deviations, perform root cause analyses, and recommend corrective and preventive actions for processes and products.

Who are we looking for?

  1. Analytical approach, structured thinker, proactive individual.
  2. Your work is of high quality and you transfer your standards and expectation of quality to your colleagues.
  3. You have a strong desire for continuous improvement.
  4. You motivate and communicate well with everyone and at all levels.
  5. You thrive on influencing others and are results-driven.

Requirements:

  1. Master's degree in Chemistry, Biotechnology, or similar.
  2. 10+ years of experience preferred from quality in relevant industries, preferably pharma/biotech.
  3. Strong knowledge of GMP and/or ISO 13485.
  4. Proven track record in managing quality projects.
  5. Outstanding problem-solving skills and ability to determine effective solutions.
  6. Strong collaboration skills to work effectively within a diverse team.
  7. Ability to compete in a fast-paced environment while strictly adhering to quality standards.
  8. Fluent (spoken and written) in English, as well as a Scandinavian language.

Please note that this position will be filled as soon as a suitable candidate is found. We look forward to receiving your application

Diversity in our teams is an important element to building an inclusive and challenging working environment. Integrity, Intensity, Innovation, and Involvement are the key 4i values of our global community.

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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