Job Information
Hologic Post Market Quality Analytics Manager CR in Alajuela, Costa Rica
Post Market Quality Analytics Manager CR
Alajuela, Alajuela, Costa Rica
Education / Educación:
Bachelor’s Degree required
Master’s Degree or Ph.D., preferred
Experience / Experiencia:
Position requires a minimum of 8-year experience in the medical industry
Position requires a minimum of 4-year experience as manager
Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
Extensive understanding of medical devices and regulatory requirements, including but not limited to:
ISO 13485
Medical Device Regulation (MDR)
CFR 820 Regulation
EU MDR Regulation
Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
English
Spanish
Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
Advanced software skills (Word, Excel, PowerPoint, Outlook)
Qualifications / Cualificaciones:
Understanding of the complaint process and applicable regulations
Excellent problem solving and analytical skills
Basic project management
Ability to influence and drive execution and change across the organization.
Demonstrated ability to develop and lead an engaged high performing team; strong leadership, collaboration, mentoring and coaching skills.
Demonstrated ability to foster a culture of engagement and growth.
Experience with complaint process and regulatory requirements
Demonstrated success leading teams, proven leadership with excellent people management and organizational skills; ability to prioritize and manage through data analysis
Strong mentoring and coaching skills. Demonstrated ability to build and lead a high-performing, motivated, and engaged team.
Ability to build strong partnerships across functions and effectively align and business goals and priorities
Curiosity and ability to ask questions and dig in data
Excellent organizational and critical thinking skills with high attention to details.
Excellent analytical and problem-solving skills on both a managerial and technical level
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
Collaborate with technical support to gather complaint information and work alongside the quality engineering team for in-depth investigations and product corrections.
Monitor data trends, identify emerging issues, and support product review boards and management reviews.
Identify and implement processes, tools, and software for effective data analysis.
Lead the integration of M&A complaint processes and serve as the subject matter expert.
Oversee activities, set goals, resource projects, and provide guidance for product support.
Recruit, retain, and manage a diverse team of direct reports.
Set expectations, establish individual goals and objectives, manage performance, and develop metrics to measure team performance.
Facilitate employee development, career planning, mentoring, and coaching to enhance engagement, innovation, and productivity.
Consistently model and promote collaboration and the sharing of information and best practices across the organization.
Build and maintain strong partnerships with functional leaders in Quality, Regulatory, R&D, Business Development, and Marketing.
Direct management of data specialists
Cross functional leadership with complaints and data trending