QUALIFICATIONS AND JOB DESCRIPTION
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
· Bachelor degree in Engineering and technical or Health/Life Sciences departments of universities.
- Min 2 years of experience in Quality Management Systems preferably in Medical Devices Industry
- Knowledge of tools/ methodologies such as design control, risk management, root cause investigation methods, process validation, statistical process control (SPC), protocol/ report preparation.
- Knowledge of ISO 13485, European Medical Device Regulation and FDA 21 CFR820 requirements, understanding the medical device regulatory environment and requirements
- Familiar with QMS processes like Technical File preparation, CAPA, Complaint management, document control etc.
- Good knowledge of MS Office applications is required and SAP is an asset
- Advanced statistical data analysis, documentation and report writing skills
- Good command of English is compulsory, German knowledge would be an asset
- Exceptional analytical, problem solving & root-cause analysis skills
- Internal auditor certification preferred
- 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
- Ability to work with and focus on details
- 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
- Be a good team player, be able to assist and support others
- Be able to meet deadlines
- Details oriented
- Results oriented
- 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
Job Description
- Responsible for providing engineering support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility
- Implementation and review or approval of of process and software verification and validation and validation plans, including Master Validation Plans and the development of process flow diagrams
- Review and approve product technical documentation acc. to applicable regulations or QMS procedures
- Lead and assist in compliance mitigation and continuous improvement projects and closing gaps, contribute in standard review meetings.
- Coordinate, prepare and schedule QMS related tasks such as technical product documentation review such as technical files, change control tasks or process validations.
- Contribute to the management of the document control system; ensure creation, changes, distribution and retention of records compliant to QMS requirements
- Quality system documentation
- Training the employees on quality related aspects
- Contribute to MAQUET’s internal audit program. Perform internal quality system audits to evaluate the quality system for compliance with applicable regulations and standards in support of continuous quality system improvement. The candidate will lead the post-audit process to ensure corrective action activities are supported by the action owners through to effective implementation.
- Nonconforming product management, effective use of QDMS system, improvement of nonconforming product management system, review of nonconformity investigations, make key decisions on the failures, making sure that closed nonconformities are totally handled in accordance with applicable regulations like ISO 13485 & 21CFR 820.