Requistion ID : 75651

　　Wellspect Healthcare är en ledande global leverantör av innovativ medicinsk utrustning som hjälper människor med blås- eller tarmdysfunktion. Wellspect har fler än 1000 anställda runt om i världen som dagligen bidrar till att göra skillnad för alla de människor som behöver företagets produkter och tjänster.

　　Wellspect är en världsledande tillverkare av intermittenta urinkatetrar, där LoFric® är det mest kända varumärket. Företaget har också utvecklat Navina™, en lösning som hjälper mot kronisk eller allvarlig förstoppning och avföringsläckage. Navina™ är förmodligen marknadens mest avancerade irrigationssystem, en smart digital lösning som kombinerar hög användarvänlighet med klinisk effektivitet.

　　Wellspect strävar efter att bli klimatneutralt med minsta möjliga påverkan på miljön. Företaget har sitt huvudkontor i Mölndal, är verksamt i över 30 länder och är en del av Dentsply Sirona – världens största tillverkare av professionella dentala lösningar. Dentsply Sirona är listat på NASDAQ i USA under symbolen XRAY.

　　Besök www.wellspect.com eller www.dentsplysirona.com för mer information.

　　Validation Engineer

　　Join our Production Development team and continue shaping medical device production systems of tomorrow.

　　As a Validation Engineer you will be a key person in the qualification and commissioning of new and improved production processes. The role will give you the chance to work with existing production processes well as development of new production processes. At Wellspect Healthcare we are proud to have a highly automated production in-house with chemical processes, multiple transport systems, packaging machines and an order controlled batch process.

　　Responsibilities

　　Develop validation strategies and validation plans in close cooperation with Production Engineers, Process Managers and external equipment suppliers to ensure our long-term product quality

　　Understanding product risks and requirements as wells as participating in process risk assessments

　　Participating hands on in validation and test run activities in clean room production

　　Conclude and report the outcome of the validation. Summarize test results and determine whether a process meets its’ acceptance criteria.

　　Develop documentation in compliance with Wellspects’ quality management system built on regulatory requirements from the European medical device directive and FDA quality systems regulations.

　　Improving process validation methods/SOPs for more efficient ways of working

　　Qualifications

　　an academic background (M.Sc./B.Sc.) with experience in Quality Management Systems /Production/Product Development Process preferably within the life science industry

　　understanding of the V-model (DQ/IQ/OQ/PQ) for process validation and the interpretation of ISO/GMP standards

　　experience in process capability measurements/calculations and other statistical analyzes

　　experience working with technical specifications and external suppliers

　　some experience from production and quality control/auditing

　　preferably some Lean/Six sigma experience

　　excellent documentation and communication skills, in English as well as in Swedish

　　We think you are a structured and proactive team player. You are open for challenges and enjoy working with many different contacts surfaces. You will be working with highly skilled and committed colleagues. Come join our team!

　　Please note that we will review applications continuously, so be sure to send in your application as soon as possible.

　　We look forward hearing from you!