Head Of Quality- Sterilization&Microbiologyology

GETINGE

Ever since Maquet's founding in Germany in 1838, it has helped hospitals with innovative products such as the first motorized operating table. A Maquet table was used for the first heart transplant surgery in 1967, in South Africa. Firsthand understanding of clinical challenges and continuous optimization of its products established Maquet as a leading provider of medical systems.  

Today Maquet is a product brand within Getinge. The Maquet brand provides a broad range of products and innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, including operating rooms, hybrid operating rooms, catheter laboratories and intensive care units as well as intra- and inter-hospital patient transportation. 

The production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US. In total, Getinge has over 12.000 employees in more than 41 countries. Getinge's head office is located in Gothenburg, Sweden.

Head Of Quality- Sterilization&Microbiology will lead the Sterilization&Microbiology Quality Team at Cardipulmonary disposables produced at Antalya site. This role will be responsible to ensure sterilization & microbiology testing activities  meet the applicable standards requirements, establishes and drives the sterilization & microbiology strategy and ensures efficiency in the execution of this work. Contributes to the related processes like change management or product technical documentation.

 This position will report to to QA-RA Director

 Job Description:

• Manage and lead the Sterilization & Microbiology Quality team.
• Establishes a culture of continuous improvement and excellence by building Sterilization and Microbiology strategy that enables the strategy via the identification and planning of key activities within the sterilization and microbiology area that ensure compliance while driving efficiencies across the organization.
• Oversee bioburden, endotoxin and environmental monitoring programs.  Ensure Implementation of  environmental monitoring and microbiological trending activities on a timely manner.
• Reporting to management and related stakeholders in the areas of sterilization and microbiological control.
• Maintain and/or support sterilization validation requirements for EO sterilization and other types of sterilization processes applicable to products.
•  Ensure compliance of Sterilization and Microbiology Processes to regulations and Getinge requirements.
•  Play an active role in Change Control Process and contribute to the process on a timely manner in terms of Sterilization and Microbiological requirements.
•  Plays a leading role in resolution of Sterilization related Quality Plans, CAPA, nonconformity or other QMS activities.
•  Provides input to Supplier Control processes in terms of external microbiological laboratories and sterilization suppliers. Coordinates with Supplier Quality and Purchasing departments.
• Plays an active role in Notified Body, FDA and other authorities audits and represents Sterilization and Microbiological topics.
•  Creates and maintains the development plans for the team members.
• Manage, follow up and report on team activities.
•  Provide guidance through the company for responsibility areas.
• Ensure team works in a compliant and efficient way.

 Qualifications:

•  University Degree in Biology, Biotechnical, Engineering or related technical disciplines,
•  Preferably a minimum of 5 years total work experience in Sterilization or Microbiology area of Medical or Pharmaceutical companies,
• Experience in leading positions,
• Knowledge of microbiological and sterilization standards and regulations: (Examples: 11135, 11137, 11737, ST72 , 10993, EP, USP),
• Good knowledge of MS Office applications is required ,
• Good command of English is compulsory,
• Excellent communication skills, and ability to lead,
• Advanced analytical, problem solving & analysis skills,
• Good knowledge of  Project management,
• Strong planning and organization ability,
•  Advanced Persuasion & Negotiation skills,