Director Investigation Unit and PMS

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 Director of Investigation Unit and PMS plays a critical role in ensuring the continued safety, quality, and performance of products after-market release. 

What will be your responsibilities? 

• Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System. 
• Directly supervises staff, which includes hiring, orienting, onboarding, training, assigning and reviewing work performance, annual work performance appraisals, and discipline. 
• Stay updated on global regulations related to post market quality standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, MDSAP, EU In Vitro Diagnostics Regulation, etc. 
• Draft and own departmental procedures (SOPs and work instruction documents and associated templates).  
• Monitor departmental key performance indicators (KPIs) and analyze for opportunities to optimize performance.  
• Uses wide-ranging experience, detailed information gathering, analysis, and investigation to resolve complex issues in innovative and effective ways. 
• Represent Post-Market Quality in cross-functional projects or teams. 
• Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to regulatory requirements for Post-Market Surveillance. 
• Collaborate with bioMerieux's leadership team for planning, execution, and oversight of the Post-Market Surveillance program and continuous process improvement and the Post-Market Surveillance Plan. 
• Align with GCS, Sites, R&D, Supply Chain, Marketing, Vigilance/RA, and IT; lead decision-oriented meetings and crisis management. 
• Supervise critical L4 investigations; challenge strategies, data, tests and conclusions; remove roadblocks. 
• Validate risk/scope assessments; Define risk & scope in TWD and determine need for Field Action Board escalation. 
• Coordinate reviewing and auditing complaint investigation records for accuracy as well as hazardous situations 
• Communicate and collaborate with external stakeholders such as customers and competent authorities 

Performs other duties as assigned

Who are you? 

• Bachelors or Master degree with 7–10+ years experience in Quality/Engineering within IVD/medical devices/biotech/software; proven people management, 
• Ability to align post-market quality initiatives with broader quality goals and regulatory landscapes.
• Deep understanding of global medical device/IVD regulations (FDA 803/806, MEDDEV, QSR 820, ISO 13485) and the ability to interpret and apply them effectively.
• Proven experience in people management. 
• Ability to guide and support peers and direct reports through technical and professional growth. Strong ability to lead and manage quality-related projects from initiation to completion.
• 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 Service, and other departments. 
• Excellent written and verbal communication skills, including justification for post market quality related decisions or processes.
• Ability to prioritize and manage multiple tasks effectively in a fast-paced environment. The 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.