Grow with us- Your Responsibilities & Tasks:

• Improve reliability of new product development processes
• Ensure company quality standards including ISO 9001, ISO 13485 and any regulatory requirement as applicable
• Review customer needs and requirements to develop effective quality assurance processes
• Review products, processes and systems on an ongoing basis to determine where improvements can be made
• Oversight the product manufacturing process to ensure quality thru the execution
• Coordinate auditors, specialist, supervisors and other staff and provide guidance and feedback
• Advise, collaborate and actively participate in production meetings with the manufacturing team
• Develop detailed reports, presentations and KPIs to appropriate executives
• Support innovation
• Maintain and support the QMS for CCM
• Support internal and external audits and technical visits
• Review and approve investigations, CAPA, change controls, procedures and all documentations related to validations and controlled documents.
• Management responsibilities for the Cell Culture Media Operations including Powder, Liquid and Advanced Therapy solutions business respective to Yauco operation
• Support the development of resources and ensure management of performance as needed

What will convince us - Qualification & Skills:

• Bachelor’s degree in engineering, Science or related field
• Minimum 5 years' quality management experience (i.e. Supervisor, Manager or leadership role)
• Certification and knowledge on ISO 900, ISO 13485 and regulated environment is a strong advantage.
• Proficiency with precision measuring tools and statistical analysis tools
• In depth understanding of quality assurance procedures and relevant legal standards
• Proficiency in regulatory aspects as customer complaints and customer observations
• Fully understanding of a QMS system and Management Process
• Excellent root cause analysis, change control management, investigation and CAPA skills
• Excellent analytical, problem-solving skills and decision making process
• Good communication, presentation, organizational and leadership skills
• Staff relations management
• Excellent teamwork, adaptability, change management, and communication skills
• Work in teams with global functions in support to the site
• Fully bilingual (English and Spanish)

What We Offer:

• Paid vacation and sick leave
• 14 paid holidays annually
• Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.
• We offer an open-office concept, a spacious outdoor area, conference areas and a development center.
• Medical, Dental and Vision insurance along with Company Retirement Plan
• On-site cafeteria and coffee shop
• On-site occupational health offices including Laboratory Services & Doctors
   

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

Please view equal employment opportunity posters provided by OFCCP here

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