The Global Product Risk Management Expert reports operationally to the Director, Global Quality, Product Development and Lifecycle Management. The role supports the Global Quality department to ensure adherence to Quality System regulatory requirements and applicable standards (e.g., ISO 14971, 13485, 9001 ).
Strong interpersonal and communication skills, and quality experience is required to closely partner with stakeholders within bioMerieux to drive continuous improvement initiatives specifically related to Product Risk Management and Post Market Surveillance processes. Main functional stakeholders include Units, Programs, Global Customer Service, and Manufacturing site Quality. The position is responsible for providing compliant and pragmatic processes and solutions to support Product Risk Management and Post Market Surveillance activities.
The Global Product Risk Management Expert is responsible for the following primary activities:
- Ensure that Quality System processes, specifically around Product Risk Management are established, implemented and maintained, and are in adherence with applicable regulations and standards.
- Work with the functional head and stakeholders to establish and align annual objectives.
- Define and manage KPIs used to measure performance related to Product Risk Management processes.
- Establish and maintain relationships with external and internal stakeholders to ensure that requirements are understood and are being achieved.
- Support the sites when preparing for internal/external inspections.
- Partner with Units and Regions to establish and provide quality system training requirements for the function to ensure compliance to appropriate regulations and standards, and adherence to internal procedures.
- Actively participate in external associations to proactively identify changes in product risk management requirements.
- Work closely with Regional, Site, Production and Development quality organization to improve the link between development and production product risk management and the link with the Post Market Surveillance process
Typical Studies-Experience, Skills and Qualifications
- Bachelor’s degree in a technical or life science (e.g., biology) area desired
- 10+ years of industry experience in the In-vitro Diagnostic field or related industry.
- 5+ years of Quality experience desired.
- 5+ years of Product Risk Management experience is required.
Skills and Qualifications:
- Demonstrates strong leadership and communication skills. The ability to multitask and provide direction/guidance by providing logical and least burdensome approach to fix quality issues and assist in the implementation of the needed improvements.
- The Quality Expert will maintain a Global perspective, understanding the regulatory context and integrate political, economic, social, technical, and cultural environments when driving solutions and/or improvements.
- Experience in participation in the management of regulatory and certification audits
Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards