Senior Quality Engineer

PowerToFly; France; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

PowerToFly is seeking a Quality Engineer to lead non-conformance investigations and ensure compliance with quality requirements. This role involves collaboration with various teams and participation in audits.

Candidates must have a Bachelor’s degree in Engineering, at least 3 years of relevant experience, and advanced English proficiency. Familiarity with quality regulations is also essential.

Join PowerToFly to impact healthcare positively with innovative solutions.

Qualifications

• Minimum 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820 and ISO 13485.
• Advanced English proficiency, written and verbal.

Responsabilités

• Lead investigations of non-conformances and implement corrective actions.
• Collaborate with Engineering and Production teams.
• Support internal and external audits.
• Monitor and analyze quality data for improvement.

Connaissances

Quality Engineering

Statistical analysis

Risk management

Audit support

Team collaboration

Formation

Bachelor’s degree in Engineering or related technical field

Outils

FMEA

Quality Management System

Description du poste

What You Will Do

• Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution.
• Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements.
• Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations.
• Escalate quality concerns to Quality Assurance and Engineering leadership and support resolution activities.
• Manage containment activities for non-conforming product, including identification, segregation, documentation, and reconciliation.
• Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities.
• Ensure compliance with the Quality Management System and applicable regulatory requirements.
• Apply statistical analysis and risk management tools, including Failure Mode and Effects Analysis (FMEA), to support decision-making and continuous improvement initiatives.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
• Advanced English proficiency, written and verbal.

Preferred Qualifications

• Experience supporting internal and external quality audits.
• Experience conducting investigations, risk assessments, and corrective and preventive action activities.
• Experience working in a regulated manufacturing environment.
• Experience using statistical analysis and quality risk management tools.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.