QUALITY ASSURANCE ENGINEER (ETO STERILIZATION)

Maquet Cardiopulmonary

Worldwide MAQUET GEtINGE GROUP ranks among the leading providers of medical technology products and services for Operating Rooms and Intensive Care Units. Since its foundation more than 178 years ago, MAQUET GETINGE GROUP has stood for innovation and technological process in the field of medicine.

The MAQUET GETINGE GROUP organization is to be found all over the world, with 27 subsidiaries on all the continents and with over 15000 employees. 

For our operation in Turkey, we are looking for a highly qualified Quality Assurance Engineer.

• University degree (Preferably Engineering Departments)
• Preferably 3 years of experience in Quality Assurance Management in medical device industry
• Knowledge of tools/ methodologies such as investigation methods, process validation, statistical process control (SPC), protocol/ report preparation
• Knowledge of ISO 13485, ISO 11135 and FDA requirements
• Good knowledge of MS Office applications is required and SAP is an asset
• Advanced statistical data analysis and report writing skills
• Good command of English is compulsory, German knowledge would be an asset
• Exceptional analytical, problem solving & root-cause analysis skills
• High level of attention to details and accuracy
• Excellent communication skills, ability to work in a team environment and lead a project team
• Ability to lead or work with multi- departmental project teams and resolve quality related issues in a timely and effective manner
• Strong interpersonal skills and problem solving ability
• High level of attention to details, timeliness and accuracy
• 6 Sigma certification preferred
• Be self-motivated, self-starter, be able to meet deadlines, be a good team player
• No military obligation for male candidates
• Knowledge of aseptic processing highly desired
• Technical drawing interpretation
• Be a good team player, be able to assist and support others
• Be able to meet deadlines
• Be self-motivated and self-starter
• Good communication skills, able to establish and maintain effective working relationship
• Be open-minded and willing to learn
• Ability to travel as required.

İŞ TANIMI

• Responsible for EO sterilization validation review and approval
• Responsible for review of sterilization process and equipment validation/qualifications (IQ, OQ and PQ)
• Review product and process change control documentation and specifications
• Coordination of sterilization qualification and requalification activities with sterilization vendors and sterilization operation team
• Overview routine sterilization process
• Responsible for conduct/review of annual revalidation and qualification activities
• Review of CTS product changes from sterilization QA perspective
• Provide non-conformance and CAPA support for NCs involving sterilization issues as needed. Responsible for support contract sterilizer NCs review and evaluation
• Contributes in trouble shooting/impact assessmnet for atypical conditions during sterilization runs/validations.
• Contributing to sterilization validation planning & reporting activities
• All other duties as assigned
• Interprets updates to applicable international  standards related with sterilization and guidelines and implements them into the quality system
• Responsible for providing engineering support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility.