Job ID :
46139BR
Location :
Sweden - Uppsala
:
Job Description
QUALITY SYSTEM MANAGER
This position is based within Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD), which has its global HQ in Uppsala, Sweden and develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,600 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.
You will also be responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPA (Corrective and Preventive actions).
• Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc.
• Serve as the Division’s Risk Manager, which includes ownership of the process as well as providing training for and follow-up of the Risk Management process.
• Give guidance on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
• Support post-market design changes, including assessment of proposed changes using design control methods.
• Participate in team projects and assignments, facilitating or leading teams as necessary.
• Identify opportunities for continuous improvement of the Quality Systems.
• Speak English and Swedish fluently and have strong communication skills, including cross-functional communication.
• Have strong interpersonal skills and drive cross-functional collaboration
• The drive to bring tasks and projects to a closure.
• Good organizational skills and the ability to define and achieve objectives for applicable projects and the processes.
• The ability to work independently, influence and negotiate with people and resolve issues.
• Have an ability to make rational, objective and appropriate decisions relating to company and department needs.
APPLY NOW on our career site http://jobs.thermofisher.com
QUALITY SYSTEM MANAGER
DESIGN ASSURANCE
UPPSALA
This position is based within Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD), which has its global HQ in Uppsala, Sweden and develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,600 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.
THE ROLE
As Quality System Manager - Design Assurance, you are responsible for supporting Product Development projects by providing the development teams with input, writing or approving Design Control deliverables such as Quality Plans, Project Plans, Document Plans, and Design History File Index.You will also be responsible for providing guidance and coaching for post market product sustaining activities, such as design changes and CAPA (Corrective and Preventive actions).
Responsibilities include:
• Establish Quality Plans for product development projects.• Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc.
• Serve as the Division’s Risk Manager, which includes ownership of the process as well as providing training for and follow-up of the Risk Management process.
• Give guidance on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
• Support post-market design changes, including assessment of proposed changes using design control methods.
• Participate in team projects and assignments, facilitating or leading teams as necessary.
• Identify opportunities for continuous improvement of the Quality Systems.
WHO ARE WE LOOKING FOR?
Someone with a university degree in medical/technical sciences and several years’ experience from the medical regulated industry, including working in a Design Assurance role.To succeed in this role you should:
• Have in-depth knowledge of working with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971) for a number of years.• Speak English and Swedish fluently and have strong communication skills, including cross-functional communication.
• Have strong interpersonal skills and drive cross-functional collaboration
• The drive to bring tasks and projects to a closure.
• Good organizational skills and the ability to define and achieve objectives for applicable projects and the processes.
• The ability to work independently, influence and negotiate with people and resolve issues.
• Have an ability to make rational, objective and appropriate decisions relating to company and department needs.
IS THIS THE OPPORTUNITY FOR YOU?
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer. What story will you tell?APPLY NOW on our career site http://jobs.thermofisher.com
