Quality Engineer Manufacturing for Mazères-sur-Salat

ThermoFisher Scientific; Cassagne; Sur place; EUR 42 000 - 65 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Quality Engineer II at the Mazères-sur-Salat site to ensure compliance with GMP/ISO standards and drive continuous improvement in manufacturing operations.

You will lead investigations, implement CAPAs, and develop robust documentation while collaborating with cross-functional teams to maintain high product quality and support audit readiness.

Qualifications

• Advanced Degree with no prior experience, or Bachelor's degree plus 2 years QA experience in GMP/ISO regulated environments.
• Fields: Life Sciences, Engineering, Chemistry or related scientific/technical field
• Strong knowledge of quality systems, cGMP regulations, and standards including ISO 9001 version 2015
• Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and documentation management.
• Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Strong proficiency in quality management software (GED, SAP QM, etc.) and Microsoft Office suite
• Experience conducting internal audits and supporting external audits.
• Demonstrated ability to build consensus and collaborate across functions
• Strong verbal and written communication skills - In French and English.
• Ability to work independently while contributing effectively in team environments
• Strong attention to detail with analytical and problem-solving capabilities
• Experience with statistical analysis tools and quality metrics reporting
• Project management skills and ability to prioritize effectively
• Foreign language skills beneficial (English)

Responsabilités

• Ensure compliance with quality standards and regulatory requirements across manufacturing operations.
• Lead investigations and implement corrective actions to maintain product quality.
• Collaborate with cross-functional teams to drive continuous improvement initiatives.
• Develop and maintain SOPs, protocols, and reports.
• Support internal and external audits and quality metrics reporting.

Connaissances

GMP/ISO knowledge

CAPA & RCA

Quality documentation

Audit experience

Cross-functional collaboration

Regulatory compliance

English & French

Statistical analysis

Problem solving

Project management

Formation

Bachelor's degree in Life Sciences/Engineering/Chemistry

Outils

GED

SAP QM

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific’s Mazères‑sur‑Salat site, we design, assemble, and qualify measurement instruments and components for laboratory analysis and process control. Here, industrial excellence meets metrological rigor: our teams develop, test, and calibrate reliable solutions for pharmaceuticals, food and beverage, environmental monitoring, and research. From production to maintenance—plus logistics for parts and consumables—we deliver performance, traceability, and high‑level technical support, helping our customers make the world healthier, cleaner, and safer.

Description

As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

Requirements

• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field
• Strong knowledge of quality systems, cGMP regulations, and standards including ISO 9001 version 2015
• Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and documentation management.
• Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Strong proficiency in quality management software (GED, SAP QM, etc.) and Microsoft Office suite
• Experience conducting internal audits and supporting external audits.
• Demonstrated ability to build consensus and collaborate across functions
• Strong verbal and written communication skills - In French and English.
• Ability to work independently while contributing effectively in team environments
• Strong attention to detail with analytical and problem-solving capabilities
• Experience with statistical analysis tools and quality metrics reporting
• Project management skills and ability to prioritize effectively
• Foreign language skills beneficial (English)

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.