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 Contacts,
Cato Svendsen
Phone: 97114506
E-Mail: cato@north-consultants.com
Linkedin: linkedin.com/in/cato-svendsen

 Due Date: 24.Apr.2023

 Location & Company,
Location: Oslo, Norway
Company: Diagnostica
Job Type: fixed

 Start Date: 24.Apr.2023

 Education: Computer Science, Master

 Industry: Healthcare
Function: Quality Management
Level: Senior.

 Experience Requirements,
Quality Management, Head of QA and regulatory affairs .
Level Senior(mandatory).
Industry Healthcare(mandatory).

QA Manager

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Welcome to the Recruitment Project for Diagnostica and the position and role av QA Manager, with focus on MDR, QA and regulatory affairs.



QA Manager, Diagnostica, The QA Manager is head of QA and regulatory affairs, document manager and responsible for testing th...
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Lead the company's QA work and ensure that the work in the company takes place within the framework set by the quality system. Ensure that the documents covered by the quality system are managed according to

regulations. Ensure that the company has the necessary tools so that document management can take place efficiently and correctly. Ensure that the documents covered by the quality system are managed according to

regulations. Ensure that the company has the necessary tools so that document management can take place efficiently and correctly.


o  QA/RA is responsible for all activities related to the QMS, Quality Control and Regulatory Affairs.

o  QA/RA represents the company to Notified Bodies, regulatory authorities as well as customers, distributors and suppliers.

o  QA/RA is responsible for overseeing the development and maintenance of quality systems as well as coordinating regulatory activities for Diagnostica. The role holds a position that necessitates a thorough understanding of key aspects of both disciplines Quality Assurance and Regulatory Affairs.




o  Management Representative (MR).

o  Person Responsible for Regulatory Compliance (PRRC).

o  Contact Person for Notified Body and Competent Authorities.

o  Organizing and performing internal and external Audits and monitoring the Imple­men­tation of Audit results.

o  Keeping the Diagnostica Quality Management System current and compliant by developing, revising, and implementing Quality procedures and policies for Diagnostica to facilitate relevant company certifications and Regulatory compliance.

o  Maintaining an up-to-date awareness of relevant legislation which may impact the QMS and communicate this effectively.

o  Promoting the benefits of the quality system to all employees.

o  Administering, preparing and conducting internal QMS audits and external supplier assurance audits as necessary.



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