The responsibility of a Sr QA Specialist also includes the maintenance and improvement of QMS compliance and effectiveness through continuous improvements and updates in response to regulatory changes.

The qualified candidate will be able to demonstrate leadership capability and skills necessary to drive continuous improvements and provide consultation and support to the organization to achieve compliant and effective processes.

This position is part of the Quality department and will be located in Solna, Stockholm, Sweden.

In this role, you will have the opportunity to:

• Represent Quality Assurance in project core teams and provide guidance and decisions to the cross-functional teams with focus on Design Control to ensure compliance with internal procedures and applicable ISO and FDA requirements.
• Build working relationships with cross functional teams including R&D, Product Transfer, Program Management, Marketing, Regulatory Affairs, Clinical Affairs and others to ensure efficient collaboration and on-time delivery of new products to the market
• Ensure that all project deliverables are executed and documented in compliance with Cepheid’s Quality Management System and applicable regulatory requirements
• Facilitate and/or assure performing Risk Management activities throughout the entire Product Life Cycle
• Work closely with R&D, Marketing, Regulatory Affairs and others to ensure that product requirements and design output meet the intended use and user needs and that Design Reviews are continuously held and documented according to established procedures
• Provide guidance to junior team members on design control best practices and interpretation of internal processes and regulatory requirements
• Collaborate with Quality Systems and Regulatory Affairs to ensure that established design control procedures in Cepheid’s Quality Management System are compliant with all relevant regulatory requirements and are updated in response to changes
• Support internal and external audits as Subject Matter Expert for Design Controls for assay projects

The essential requirements of the job include:

• University’s degree within Molecular Biology, Applied Sciences, Biotechnology or Biomedical Engineering
• Minimum 5 years of relevant experience in Quality working with development of IVD tests, or similar experience from related areas
• Experience from implementing design control and leading risk management activities in medical device/diagnostic industry
• Strong understanding of quality systems methodology and applications
• Demonstrated knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, ISO 13485 and ISO 14971
• Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products
• Have strong interpersonal, writing and communication skills; fluent English in written and spoken; Swedish is an advantage
• Wants to work in a fast-paced environment with and manage continuous changes and improvements
• Dedication to product quality and customer satisfaction
• Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals

It would be a plus if you also possess previous experience in:

• Demonstrated knowledge in Molecular Biology and/or Virology or similar with understanding of relevant aspects for PCR based molecular tests.