Senior Complaint Specialist

Getinge AB / Organisationsutvecklarjobb / Solna
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The position

In this position you will be responsible for handling complaints and be our expert in global authority reporting. You will be a part of a learning organization by working with continuous process improvements and contributing to fulfill the department goals. You will interface with different stakeholders across the organization, (for example within Quality, Manufacturing Operations, Engineering, Supplier Quality, R&D etc.) regarding identification and resolution of complaints.



Among your main responsibilities and tasks will be:


Make decisions regarding authority reporting etc.
Leading and participating in investigations
Participate in Risk assessment
Create reports to authorities and response letters
Reviewing investigation reports
Be an expert in applicable laws/requirements within complaint handling
Participate in internal/external audits
Contribute to improvement of existing SOPs



The position is located in Solna and reports to the Director of Customer complaints department. Limited traveling is required in this role.

The ideal candidate

As ideal for the position you have a minimum of 5 years' experience from similar work tasks together with an academic degree in Science or Engineering or a Quality education. Experience from a regulatory environment is necessary and a background from the Med-Tech industry or Clinical application is favorable. You have documented knowledge in regulatory demands like ISO 13485, CFR 21 Part 820 and MEDDEV 2. You are fluent in Swedish as well as in English, which is our corporate language.



As a person you are a goal-oriented and a cooperative team-player who drives results and takes responsibility. You have a structured, accurate and solution-oriented attitude and are stimulated by running many parallel activities. Being able to communicate efficiently with different stakeholders is important in order to succeed in the role. An ability to work in a changing environment is also a key factor for this position.

Getinge Group is in an exciting and intensive period of change and you will be a key player as we are building a new Quality Regulatory Compliance (QRC) organization. We are strengthening our Business Category Unit in Acute Care Therapies (ACT) at the manufacturing site in Solna by recruiting a structured and goal-oriented Senior Complaint Specialist. Our Customer Complaint department focuses on the post market surveillance of the globally installed base of ACT products. We perform complex technical investigations, manage authority reporting and provide feedback to customers regarding investigation results. The department plays a significant role in understanding the customers' needs during the complete products' lifecycle and contributes to maintaining safe products. You will be part of the Authority reporting team, where you have the possibility to contribute to its development.

Publiceringsdatum
2017-03-22

Så ansöker du
Sista dag att ansöka är 2017-04-10

Kontakt
Magnus Lindqvist Magnus.Lindqvist@getinge.com

Företag
Getinge AB

Adress
Getinge AB
Röntgenvägen 2
17106 Solna

Kontorsadress
Röntgenvägen 2

Jobbnummer
3390467

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