Manager of Quality

Sartorius

Yauco, PR
Permanente
Tiempo completo

Hace 29 días

The Manager of Quality will be responsible for overseeing the operation of the manufacturing department and the efficacy of the overall program to make sure it has been built with compliance to legal standards and meets customer expectations. The holder of this position will also drive continual quality improvement within the facility. The goal is to help preserve our reputation by ensuring that our products and services are capable to drive sustainable growth.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 hereE-Verify Participation InfoE-Verify Workers RightsAbout SartoriusSartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.Join our global team and become part of the solution. We are looking forward to receiving your application.

Sartorius

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