Validation Engineer - Dentsply Ih Ab - Wellspect Healthcare - Kemiingenjörsjobb i Mölndal
Validation Engineer
Dentsply Ih Ab - Wellspect Healthcare / Kemiingenjörsjobb / Mölndal
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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, combining a high degree of user convenience, clinical effectiveness and connectivity into one really smart system. Wellspect HealthCare has a presence in more than 30 countries, and is a part of Dentsply Sirona.

Publiceringsdatum
2017-09-06

Ersättning
Individuell månadslön

Så ansöker du
Sista dag att ansöka är 2017-09-24
Ange följande referens när du ansöker: 48964
Klicka på denna länk för att göra din ansökan

Kontakt
Thomas Börstell +46 31 376 43 25

Företag
DENTSPLY IH AB - Wellspect HealthCare

Adress
DENTSPLY IH AB - Wellspect HealthCare
Box 14
43121 Mölndal

Kontorsadress
Aminogatan 1

Jobbnummer
3682718

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