OBS! Ansökningsperioden för denna annonsen har
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Arbetsbeskrivning
Job description
We are looking for an experienced Software Quality Specialist to join a growing team at Cepheid, a Diagnostics company located in Solna, Stockholm. At Cepheid, Software Engineering and Software Quality work in cross-functional agile scrum teams developing cloud services for disease surveillance and systems administration in the diagnostics area.
The Sr. Software Quality Specialist’s primary responsibility is software validation and representing Software Quality in software development project core teams.
Core team representation includes ensuring that the project follows established procedures, that deliverables are generated and have the proper content, leading risk management activities and ensuring that risk management is integrated into the entire development process.
Software validation is the main activity for this role, and includes planning the validation activities, participating in generation/execution of validation, and creating the validation report.
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.
Responsibilities
Job responsibilities include:
Work closely with Software Engineering, Product Owner, Global Product Support and others to ensure product requirements and design meet intended use and user needs.
Review and approve project documentation for compliance towards Cepheid’s Quality Management System and relevant regulatory requirements.
Lead and participate in all Risk Management activities through out the entire Product Life Cycle.
Build working relationships with cross functional teams including Software Engineering, Program Management, Product Owner, Regulatory Affairs, Global Product Support and others to ensure efficient collaboration and reduce product time to market.
Participate in and ensuring that Design Reviews are continuously held and documented according to established procedures.
Work closely with Quality Systems and Regulatory Affairs to ensure that established procedures in Cepheid’s Quality Management System are compliant with applicable global regulatory requirements.
Participate in failure investigations of customer complaints to ensure compliance to regulatory requirements, and that complaint resolution conforms to intended use and user needs.
Support internal and external audits as Subject Matter Expert for Design Controls for software projects.
Qualifications
To succeed in this position you need to have:
A Bachelor’s degree, Master’s degree or PhD within Computer Science, molecular biology or similar.
Minimum 7 years of experience in Software Quality Assurance role working with
Software Validation.
Experience from working in medical device/diagnostic industry, or other regulated industry, for example pharma, railroad or automotive.
Experience from working with Medical Device Data Systems, Cloud Deployed
Software or similar in a regulated environment.
Strong understanding of quality systems methodology and applications.
Full working proficiency in English.
If you also have any of the following, it will be considered a merit:
Training and certification in Medical Device Software, Software Validation, Lean Principles etc.
Experience from leading risk management activities.
Experience from working within Life Sciences or Biotechnology industry.
Experience in SCRUM, Continuous improvement or Cyber security.
As a person you possess excellent analytical and troubleshooting skills. You are goal oriented, self-motivated and willing to learn new concepts, technologies and products. A fast-paced environment with continuous improvements suits you well. You have strong interpersonal, writing and communication skills.
Application
In this process, Cepheid cooperates with Randstad Life Sciences and Engineering. We need your application as soon as possible as we continuously interview to find the right candidate.
For questions, please contact recruiter Åsa Vallin, asa.vallin@randstad.se, +46 73 343 40 45 or recruiter Linnéa Edvardsson, linnea.edvardsson@randstad.se, +46 72 516 89 09.
About the company
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all!
Kontaktpersoner på detta företaget
Daniella Petersen
Cecilia Mannheimer
Emelie Özgun
Pontus Adolfsson
Konsultchef Katja Löfström
Maria Johansson
Maria Öhlander
072-9889604
Jonna Blom
Emelie Özgun
0729889603
Konsultchef Camilo Garcia Sanchez
0729889044