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Quality Engineer (f/m) Medical Technology de Lund em Stryker Corporation

Data de Postagem: 4/19/2019

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Descrição do Emprego

The LUCAS chest compression system was invented and developed in Lund, Sweden, and is today used globally by ambulance and hospital professionals to save sudden cardiac arrest patients. As a Quality Engineer you could be part of this dedicated team. We have a mission-oriented culture, are energized by the knowledge that our products save lives every day.

Your key responsibilities

In the role of Quality Engineer, you are the link between Quality, Development, Operations and Clinical Affairs. Your daily work will focus on Quality System development, Risk Management and Design Controls in accordance with ISO 13485, MDD/MDR & QSR. You will also assist in the handling of Non-conformities, corrective and preventive Actions (CAPAs) and Audit findings as well as participating in and leading Quality System related projects. As Quality Engineer you will be a part of the quality department and report to the Quality & Regulatory Affairs Manager. You are operating in a dynamic international environment as part of a global company. Corporate language is English, in the office we speak Swedish. Other responsibilities can be:

  • Quality assurance activities in projects.
  • Maintenance and continuous improvements of the Jolife Quality Management System (QMS).
  • Perform quality audits and coordinate the closure of findings.
  • Maintain regulatory documents library and keep it up to date.
  • Perform gap analysis for new or updated regulatory requirements and identify potential gaps in the QMS.
  • Review and follow up on supplier’s quality assurance activities.
  • Perform quality check of released products (Extended Delivery Check).
  • Coordinate calibration activities and maintain calibration list.

What are we looking for

To succeed in the role of Quality Engineer you are a driven and systematic person with a passion for structure, processes and quality. You are a communicative person who can transfer skills and knowledge in an informative

and easy digestible way. You are clear in your message and not afraid to question if needed. Experience from working in the medical device industry, as well as skills in quality auditing, is preferable.

Furthermore, you enjoy working in an international environment characterized by high quality demands, regulations and standards. You work independently and take own initiatives. In addition to a university degree in engineering or similar, you have a good understanding of risk management, process development and are experienced in working in and/or managing projects. You use English fluently in speech and writing, as well as speaking Swedish fluently.

Your contact

If you have any questions regarding this vacancy, feel free to reach out to the responsible Recruiter Torben Olde.

About the company

Jolife AB, a wholly owned company by Physio Control Inc/Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).

Work From Home: No

Travel Percentage: None

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