Quality and Regulatory Manager
Getinge Group AB / Organisationsutvecklarjobb / Halmstad
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hela Sverige Every day, Getinge Group products contribute to saving lives and ensuring excellent care. All across the world, our people make a huge difference for patients, healthcare professionals and societies. And we are very proud of that.
We are now recruiting a Quality and Regulatory Manager for Getinge Sterilization AB, which is part of Getinge group, center of excellence for sterilization. We develop and manufacture units sold worldwide for the healthcare sector as well as highly customized units for the BioPharma and BioMedical sector. Getinge Group is in an exciting and intensive period of change and you will be a key player when it comes to ensuring high quality of products, policies and processes at our local manufacturing site. This is a unique opportunity to contribute to developing the quality organization and to interface with a wide variety of key stakeholders. As the ambassador of the Group Values, you will work for a sustainable working culture.
The position
In this position you will have overall responsibility for quality management and quality assurance within the local manufacturing site. The primary purpose of this role is to develop, define and revise quality assurance system, policies, procedures and controls, to ensure company and products comply with applicable regulations and laws. You will represent the local executive management team in terms of Quality Management System.
Among your main responsibilities and tasks will be:
• Represent local management during external audits and inspections
• Develop and monitor quality objectives in the area of quality assurance and quality management activities
• Measure and monitor performance of the processes, analyze and report the quality performance measurements to top management
• Ensure effective document control & records control processes are developed and maintained
• Organize and prepare management review meetings
• Prepare audit schedules, execute internal audits and evaluate audit reports
• Identify and direct continuous improvement projects and CAPAs.
• Apply for and maintain product approvals e.g. CE marking; 510(k) (if applicable) and technical file.
• Coordinate and perform environmental management meetings, annual review of environmental aspects. Ensure surveillance of environmental laws and directives
The position is located in Getinge, Halmstad. Some travelling is required and estimated to around 10%. The position reports directly to the QA Director Capital Equipment and with dotted line to the Site Managing Director.
The ideal candidate
As ideal for the position you have the following key characteristics:
• Minimum 5 years of experience from a similar position in the medical device industry
• Previous background in quality assurance and manufacturing
• Strong knowledge in standards and regulatory demands, such as ISO 13485, CFR 21 Part 820 and 11 and ISO 14001
• Documented successful leadership experience
• Bachelor's degree in science or engineering
• Fluent spoken and written Swedish and English
As a person you are a collaborative team-player with strong leadership and interpersonal skills. You have excellent listening skills and an ability to develop people and interact with all levels of the organization. You have a structured personality and make sure actions are implemented. Being solution-oriented and open to changes are also important competences to succeed in this role.
Application
Are you interested in becoming part of an international and market leading medical technology company whose products make a huge difference for patients, healthcare professionals and societies all around the world? Getinge offers a great opportunity to make a difference in a global and dynamic environment!
Welcome with your application no later than 23rd of March if you are interested in the position. You are also welcome to contact Katarzyna Bobrow, QA Director Capital Equipment at
katarzyna.bobrow@getinge.com or Anna Eklöf-Persson, Managing Director, at
anna.eklof-persson@getinge.com if you have questions.
Background checks may be carried out.
Varaktighet, arbetstid
Heltid Tills vidare
Publiceringsdatum2016-03-01ErsättningFast
Så ansöker duSista dag att ansöka är 2016-03-23
Klicka på denna länk för att göra din ansökanFöretagGetinge Group AB
AdressGetinge Group AB
P.O Box 8861
40272 Göteborg
KontorsadressP.O Box 8861
Jobbnummer 2699706
Observera att sista ansökningsdag har passerat.