Post Market Quality Investigation Expert- IT Solutions & Sequencing F/M/D

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

The Investigation Unit Expert reports to Quality Director of the IT Solutions & Sequencing Franchises and works closely with the Post-market and QA R&D team.

She/He plays a pivotal role in ensuring quality, safety, and performance of products post-market release. This role involves leading escalated investigations into quality-related issues identified through post market trend monitoring, changes in product reliability, and customer complaints. Working with cross-functional teams, the expert will coordinate the identification of product risks and mitigations, aid in initiation and participation of corrective and preventive actions and communicate with vigilance for potential field actions. Additionally, the expert will oversee the reporting and presentation of findings and recommendations to management and stakeholders and prepare for and assist with audits and other regulatory inspections as directed. The expert will possess comprehensive knowledge of procedures and regulations to make informed decisions regarding procedural updates and application of procedures. 

The position is based in La Balme site OR Marcy l’Etoile (“historic” site).

What will be your responsibilities?

• Validate the need for Level 4 escalation of complaint(s) or trends when linked to product quality issues.  
• Lead escalated complaints investigations, involving relevant cross-functional contributors. Define and document the investigation plan, scope, milestones and due dates, and maintain stakeholders’ alignment. 
• Coordinate the hazard assessments and trigger the escalation to field action when needed  
• Consolidate and document technical data, identify deep root-cause(s) and influence the decision for CAPA and product/process changes 
• Representing post market quality in cross functional committees for complaints management
• Be accountable for the investigation methodologies and own local procedures/templates  
• Clearly communicate aspects of post market investigations to quality management and external team management 
• Perform all work in compliance with company policy and within the guidelines of bioMérieux’s Quality System
• Stay updated on global regulations related to post market quality
• Foster a culture of continuous improvement throughout the organization
• Identify and contribute to investigations into improvement projects, as needed. 
• Act as a post market quality subject matter expert during regulatory inspections and audits, as needed. 

Who are you?

• 7+ years in Quality Engineering within reagents, equipment and/or software environment or related roles within IVD, medical devices, biotech.
• Able to lead a cross-functional team 
• Able to animate and synthesize technical working sessions and to make data-driven decisions
• Able to begin, lead and oversee complex topics, including in crisis mode, independently.
• Able to reflect and question assumption without line authority
• Fluency in English and in French, ability to work in a multi-site, international environment.
• Ability to think strategically, identify and mitigate quality-related risks and maintain regulatory compliant processes and procedures.
• Personable and service oriented with attention to detail, excellent organizational and time management skills.
• Foster and sustain robust, productive, cross-functional relationships with teams in R&D, Quality (Quality Assurance/Quality Control), Manufacturing, Customer Support, and other departments.
• Excellent written and verbal communication skills, including justification for post market quality related decisions or processes.
• Comprehensive knowledge of regulations applicable to medical device/IVD industry (FDA 806 & 803, MEDDEV, QMS requirements (QSR 820 and ISO 13485)). Must be able to interpret regulatory requirements, determine needs for maintaining compliance, and effectively communicate this information to stakeholders.
• Ability to work closely with management to identify and communicate areas of technical, schedule, and budget risk.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.