Manager of Quality
Sartorius
- Yauco, PR
- Permanente
- Tiempo completo
- 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
- 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)
- 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