Quality Engineer: NPI & Compliance Lead in Life Sciences

ThermoFisher Scientific; Oslo; Sur place; NOK 750 000 - 950 000; Plein temps

Résumé du poste

Thermo Fisher Scientific Norway is seeking a Quality Engineer in Oslo. You will help ensure products, processes, and quality systems meet applicable standards and regulatory requirements, supporting new product introductions and continuous improvement.

You will lead risk assessments, validation activities, investigate deviations with cross-functional teams, and provide guidance across projects. The role requires an advanced degree and at least 3 years QA experience in regulated industries, with

Qualifications

• Advanced degree and minimum 3 years in QA in a regulated industry.
• Background in Life Sciences, Engineering, Chemistry, Biology or related field.
• Strong knowledge of GMP/GxP and ISO 9001/13485.
• Experience with CAPA, deviation management and change control.
• Experience with validation/qualification activities.
• Excellent analytical, problem-solving and attention to detail.

Responsabilités

• Ensure compliance with quality standards and regulatory requirements.
• Lead Design Compliance and Quality in New Product Introduction (NPI) projects.
• Lead risk assessments and the development of mitigation strategies.
• Support validation and qualification of instruments, software, manufacturing processes, and analytical methods.
• Investigate deviations with cross-functional teams, perform root cause analyses, and support CAPA.
• Provide quality expertise and guidance across functions and projects.

Connaissances

Quality Assurance

GMP/GxP Knowledge

CAPA & Deviation Management

Risk Assessment

Root Cause Analysis

Validation & Qualification

Cross-Functional Collaboration

Analytical Thinking

Communication Skills

Fluency in Norwegian & English

Formation

Advanced degree in Life Sciences/Engineering/Chemistry/Biology

Outils

Quality Management Systems (QMS)

Description du poste

Thermo Fisher Scientific Norway is seeking a Quality Engineer in Oslo. You will help ensure products, processes, and quality systems meet applicable standards and regulatory requirements, supporting new product introductions and continuous improvement.

You will lead risk assessments, validation activities, investigate deviations with cross-functional teams, and provide guidance across projects. The role requires an advanced degree and at least 3 years QA experience in regulated industries, with