QA R&D Quality Lead

QA R&D Quality Lead

Letar du efter en karriär som har betydelse?
Vi anser att varje person förtjänar en chans till ett hälsosamt liv, fritt från sjukdomar och fullt av möjligheter. Vi ser en värld full av läkande, med livskraftiga vårdalternativ tillgängliga för dem som idag har begränsade möjligheter. Vi föreställer oss nya sätt att ge läkare, farmaceuter och sjuksköterskor teknik som inte bara behandlar kroniska sjukdomar, utan som även arbetar för att förebygga dem. Vi letar efter teammedlemmar som är motiverade att lära, växa och förnya sig, samtidigt som de bidrar till att göra betydande skillnad för miljontals människor runt om i världen.

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Summary
Within this role as a QA R&D Quality Lead you will be responsible for coordinating all QA activities within development projects for the entire life cycle of new product development and changes onsite in Lund. Your main tasks will relate to improving the quality and reliability of our products, supporting and working closely with stakeholders and R&D counterparts.

Essential Duties and Responsibilities
  • Establish and maintain quality plans in development projects and throughout product lifecycle. This includes timely and effective execution of quality plan including fulfillment of KPIs and metrics
  • Ensuring compliance to design control and change control processes
  • Supports audits and inspections, including preparation
  • Participate in design reviews
  • Review and approve design control and product risk management deliverables
  • Review and approve Clinical Evaluation Reports, conformity to applicable standards, clinical trial protocols
  • Review and approve verification and validation deliverables, sampling plans and statistical analysis of test results.
  • Review Design History File (DHF) in depth prior to final design reviews
  • Reject and veto deliverables/design reviews which are not adequate, not based on objective evidence, or not compliant to regulations or processes
Qualifications
  • A Bachelor's Degree or equivalent in science or engineering
  • Minimum of 3 years from Medical Device industry, research and development, pharmaceutical, quality and/or regulatory employment experience and 1 year working with design control.
  • Knowledge in quality engineering methods including (eg: QFD, DoE, statistical techniques, Six Sigma, Root Cause Analysis, Pareto, Ishikawa, Risk Management, etc)
  • Fluent in Swedish and English Required
  • You will confidently work independently and you hold excellent problem solving, communication and analytical thinking skills
  • You will be able to work within cross functional teams and to work as part of a global team, including Asia and United States.
What we offer
  • A challenging opportunity for you and also a chance to work in a diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
  • Independent position with an opportunity to build your own strategy and make a real impact
  • A chance to further build your professional experience in the area of health care
  • Internal training tailored to business needs and career goals
  • Stability of employment in a recognizable and established company
Mer info
Område Lund
Yrkesroll Organisation & ledning, Affärsutvecklare
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 24 apr 2020 (16 dagar kvar)