Quality & Compliance Specialist, Analytical Instruments

ThermoFisher Scientific; Breda; On-site; EUR 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality and Compliance Specialist to ensure regulatory compliance and drive continuous improvement of quality systems across multiple sites in the Netherlands, Denmark, Sweden, the UK and Belgium. You will work with cross-functional teams and a global quality organization to investigate issues, manage audits and oversee CAPA processes.

The role requires advanced degrees or equivalent experience, strong knowledge of GMP/GLP and ISO standards, and excellent

Qualifications

• Advanced degree plus years of work experiences, or Bachelor's Degree plus 5 years in quality assurance.
• Knowledge of EU or USA GMP and GLP regulations plus IQ, OQ, PQ (min 3 years proven) and ISO 9001/13485/17025.
• Experience with quality management systems, CAPA, deviation management and change control; internal auditing experience.
• Root cause analysis and investigation techniques; corrective action implementation.
• Proficiency in statistics, data trending and quality metrics reporting; strong technical writing.
• Fluency in English; Dutch or German language skills preferred.

Responsibilities

• Develop and maintain the data infrastructure for the IES EMEA Quality Team, manage SharePoint sites, workflows and reporting tools, and document control.
• Develop and maintain required certifications for IES sites in scope (ISO 9001:2015/ISO 17025).
• Support quality management needs for IES Enterprise Services across countries in scope; drive continuous improvement.
• Coordinate quality activities with local management, employees, suppliers and customers.
• Create and maintain SOPs, investigations and quality tools on SharePoint.
• Support quality agreements and service contracts with vendors.

Skills

Quality assurance

Auditing

Root cause analysis

Statistical analysis

Documentation

English fluency

Cross-functional collaboration

Education

Advanced degree

Bachelor's degree

Tools

SharePoint

MS Teams

Job description

Thermo Fisher Scientific is seeking a Quality and Compliance Specialist to ensure regulatory compliance and drive continuous improvement of quality systems across multiple sites in the Netherlands, Denmark, Sweden, the UK and Belgium. You will work with cross-functional teams and a global quality organization to investigate issues, manage audits and oversee CAPA processes.

The role requires advanced degrees or equivalent experience, strong knowledge of GMP/GLP and ISO standards, and excellent