Supplier Quality Assurance Engineer

GETINGE GROUP

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.

Qualifications:

·University degree (Preferably Engineering Departments).

·Preferably 2 years of experience in Supplier Quality Assurance fuctions in medical device industry.

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

·Knowledge of ISO 13485, ISO 9001, ISO 17025, ISO 19011 and FDA requirements for medical devices. Auditor certificate for one of these standards is an asset.

·Good knowledge of MS Office applications is required

·Knowledge of SAP is an asset

·Advanced statistical data analysis and report writing skills.

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

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

·High level of attention to timeliness, details and accuracy

·Excellent communication and negotiation 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, organizational skills and problem solving ability

·Ability understand supplier requirements, product safety requirements and work accordingly

·Be self-motivated, self-starter.

·Knowledge of the cleanroom principles and ETO sterilization process is an asset.

·Be open-minded and willing to learn

·Result oriented, be able to follow-up

·Ability to travel as required

·No military obligation for male candidates.

Job description:

·Responsible for ensuring quality and compliance in accordance with documented procedures for all aspects of functional responsibility of the Supplier Quality Assurance Engineer

·Maintains related Quality System documentation

·Trains the site employees on the supplier quality related aspects

·Contributes to SCAR / NC management, effectively uses the QDMS system and global tools, working on improvement of the supplier quality related process

·Plays a major role in the key decisions on the supplier / material related failures, making sure that closed nonconformities are totally handled in accordance with applicable regulations like ISO 13485 & 21CFR 820

·Plans and conducts supplier audits, writes reports and follows up the actions

·Performs supplier evaluations and presents the data to suppliers and management when required

·Plays a major role in trouble shooting/impact assessment processes for supplier related deviations

·Interprets updates to applicable international standards and implements them into the internal quality system

·Performs trend analysis within the responsibility areas and contributes to actions and improvement projects

·Leads and/or contributes to project management relating to Supplier Quality Assurance

·Creates rutin supplier quality related reports and presents them to the local and global management

·Plays active role in the supplier qualification process

·Creates, negotiates and reviews supplier agreements