QUALITY ASSURANCE ENGINEER

GETINGE GROUP

Worldwide MAQUET ranks among the leading providers of medical technology products and services for Operating Rooms and Intensive Care Units. Since its foundation more than 175 years ago, MAQUET has stood for innovation and technological process in the field of medicine.

The MAQUET organization is to be found all over the world, with 36 subsidiaries on all the continents and with over 250 specialist distributors and partner companies in sales and service representing MAQUET. Centers of excellence are located in Germany, France and Sweden.

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

Qualifications:

·University degree (Preferably Engineering Departments).

·Preferably 3 years of experience in Quality Assurance fuctions in medical device industry.

·Knowledge of tools/ methodologies such as nonconformity management, investigation methods(fish bone-5why-process mapping etc.), process validation, statistical process control (SPC), protocol/ report preparation.

·Knowledge of ISO 13485, ISO 11135 and FDA requirements for medical devices.

·Good knowledge of MS Office applications is required.

·SAP is an asset.

·Advanced statistical data analysis and report writing skills.

·Good command of English is compulsory, German knowledge would be an asset.

·Advanced analytical, problem solving & root-cause analysis skills.

·High level of attention to timeliness, details and accuracy.

·Excellent communication skills, ability to work in a team environment, being able to assist and support others in the team.

·Being able to contribute to positive work environment.

·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.

·Ability understand customer requirements and product safety requirements and work accordingly.

·6 Sigma certification preferred.

·Be self-motivated, self-starter.

·No military obligation for male candidates.

·Being familiar with cleanroom principles and ETO sterilization process.

·Technical drawing reading.

·Be open-minded and willing to learn.

·Results oriented.

·God English writing and speaking.

·No military

·Ability to travel as required.

Job description:

·Responsible to contribute ensuring quality and compliance in accordance with documented procedures for all aspects of functional responsibility of Quality-Regulatory-Compliance function.

·Quality system documentation.

·Training of the site employees on quality related aspects.

·Contribute to nonconforming product management, effective use of QDMS system and global tools, improvement of nonconforming product management system, review of nonconformity investigations, contribute to key decisions on the failures, making sure that closed nonconformities are totally handled in accordance with applicable regulations like ISO 13485 & 21CFR 820.

·Responsible to release products after sterilization process on a routine basis.

·Contribute to EO sterilization validation studies, review and approval.

·Responsible for review of sterilization process and equipment validation/qualifications (IQ, OQ and PQ)

·Overview routine sterilization process.

·Contributes in trouble shooting/impact assessment for deviations found during sterilization runs/validations.

·Contributing to sterilization validation planning & reporting activities.

·Interprets updates to applicable international standards related with sterilization and guidelines and implements them into the quality system.

·Customer complaints registration, investigation coordination.

·Closure of customer complaints in a timelly and compliant manner.

·Giving feedback to the customers and global organization on complaints.

·Working with global and local organization for the responsibility area.

·Trending data from responsiblity areas and contributing to actions and improvement projects.