Validation Engineer
Dentsply Ih Ab - Wellspect Healthcare / Kemiingenjörsjobb / Mölndal
2018-02-05
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hela Sverige Visa alla jobb hos Dentsply Ih Ab - Wellspect Healthcare i Mölndal 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. 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.
Your key accountabilities are;
• 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
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.
We believe you have
• an academic background (M.Sc./B.Sc.) with experience in process validation 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
• 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
Wellspect Healthcare, with headquarters in Mölndal, Sweden, is a leading global provider of innovative medical devices with a focus on helping people suffering from urinary retention or chronic constipation. Every day, more than 1 100 employees are dedicated to make a difference for those who need our products and services. Many of the people we serve have a spinal cord injury, enlarged prostate, spina bifida or multiple sclerosis. We are one of the world's leading manufacturers of intermittent urinary catheters, with LoFric® as our most known brand. As a help to those with chronic or severe constipation we have developed what likely is the world's most advanced irrigation system, the Navina SystemsTM. Wellspect HealthCare has a presence in more than 30 countries, and is a part of Dentsply Sirona. Visit
www.wellspect.com and
www.dentsplysirona.com for more information.
Publiceringsdatum2018-02-05ErsättningIndividuell månadslön
Så ansöker duSista dag att ansöka är 2018-02-26
Ange följande referens när du ansöker: 52547
Klicka på denna länk för att göra din ansökanKontaktThomas Börstell +46 31 376 43 25
FöretagDENTSPLY IH AB - Wellspect HealthCare
AdressDENTSPLY IH AB - Wellspect HealthCare
Box 14
43121 Mölndal
KontorsadressAminogatan 1
Jobbnummer 3946633
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