Supplier Quality Engineer

GETINGE GROUP

Together we can make a difference

At Getinge, we have a firm belief that every person and community should have access to the best possible care.  That is why we are dedicated and passionate about helping our customers save lives and ensure excellent care.  We provide products and solutions for hospitals and life science institutions within the areas of intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science.  A career at Getinge will provide career opportunities that both inspire and challenge.  Here, you can make a difference every day.

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
• Good command of English is compulsory, German knowledge would be an asset
• 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 CFR 820  requirements, understanding the medical device regulatory environment and requirements
• Knowledge of ISO 11135, ISO 11137, ISO 11737-1, AAMI ST72 etc. related EO/Gama Sterilization, Bioburden, LAL and Environmental Monitoring System regulations preferred
• Familiar with QMS processes like Technical File preparation, CAPA, Complaint management, document control, internal audit etc.
• Good knowledge of MS Office applications is required and SAP is an asset
• Statistical data analysis, documentation and report writing skills
• Internal auditor certification preferred
• 6 Sigma certification preferred
• 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
• Be self-motivated, self-starter, be able to meet deadlines, be a good team player, be able to assist and support others
• Result oriented
• Be open-minded and willing to learn
• Ability to travel as required

 Job Description :

Quality Assurance – Supplier Controls :

• Supplier audits (global and local)
• Control and approval of supplier qualification
• Control and approval of the approved supplier list
• Trend and support of SCAR
• Control and approval of supplier evaluation
• Controlling the preparation and signing process of supplier contracts
• Follow-up of supplier related changes
• Support to the supplier related nonconformity management process