QMS Leader
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services to our customers and help them work, faster and safer, leading to better patient outcomes.
We are looking for a Quality Management System Leader (ISO 9001) to work with our expert Quality and Regulatory Affairs team of over 200 employees across the world. Do you have a passion for Quality Assurance? Then we would love to hear from you.
What you'll do
Provide comprehensive ownership of the Cytiva Quality Management System (QMS) according to ISO 13485 requirements. Run and deliver compliant, prioritized and customer focused QMS.
Provide leadership and oversight to ensure Procedures, Work Instructions, and support tools such as Guidance Documents, Subject Matter Experts engagement, communication, training and effectiveness monitoring result in a robust, compliant and executable Quality System.
Understand external requirements and expectations, user and business needs and take proactive measures to leverage the QMS as a competitive advantage for the business.
Develop, implement, continuously improves and support applicable QMS eDMS system(s), ensuring compliance, usability, effectiveness and efficiency.
Develop QMS relevant processes, improvement plans & lead efforts to reduce risk through evaluation of internal and external feedback.
Ensure process efficiency and compliance effectiveness by working with documentation control and training teams
Support sites in maintaining QMS (adding/removing documents) while ensuring alignment with global procedures, and subject matter experts' recommendations.
Perform audits to monitor the effectiveness of QMS/processes at sites while ensuring independent audits or self-assessment on the global QMS processes/effectiveness are in place. Act on findings and recommendations. Drive execution rigor.
Interface with leadership on various initiatives to support strategic decision making, maintain strong communication, and establish cross functional operating mechanisms
Drive opportunities to leverage best practices across the business
Who you are
Bachelor's Degree and minimum of 10 years working in a regulated medical device industry. Desired: Master's Degree or PhD in Engineering or Technical Discipline
Quality Assurance/Quality Engineering experience in the medical device industry or experience in design engineering or manufacturing engineering in the medical device field
Exceptional analytical, problem solving & root-cause analysis skills.
Excellent communication skills (written and oral)
Experienced in managing project teams and working cross - functionally and at global level
Demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services)
Familiarity with the quality improvement using tools (LEAN six sigma, SPC and data trending)
Please submit your application in English!
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you'll feel right at home here. If you're flexible, curious and relentless, you'll belong. If you are excited about a global culture, this can be the place to further your career.
Publiceringsdatum2020-04-28Så ansöker duSista dag att ansöka är 2020-05-17
Klicka på denna länk för att göra din ansökanAdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare GE Healthcare Bio-Sciences AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Jobbnummer 5205609
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