Norlase is a fast-growing medical device company, successfully developing next-generation laser-based medical devices, based on break-through technology. Norlase was founded by Danish and US serial entrepreneurs and is backed by VC-investors. In the past 24 months, we have grown from 5 to 15 fulltime employees and have recently moved to new production facilities in Ballerup.
You will be referring to the VP of RA&QA. As Quality ambassador in our production area, you will be accountable for ensuring the necessary quality level in an efficient and balanced way, together with the production team.
Overall focus is Quality Assurance in the production area including:
- Driver of non-conformance handling
- Facilitate ECO meetings and ECO processes ensuring cross department conformance
- Maintain process FMEA and process qualification/validation to improve quality
- Coordination of supporting quality disciplines such as: Environmental control, calibration, document control in production, compliance to EN 13485 / QSR 820
- Quality anchor in production area when we implement changes such as ERP system, production/process improvements, LEAN improvement projects etc.
- Quality assurance of incoming control of goods and for final release of finished devices
- Assists product development in securing regulatory approval of new products as needed
The candidate is capable of implementing and maintaining solid and pragmatic solutions in our production. The candidate might not have experience in all of the specific disciplines but is a fast learner and eager to expand his/her area of expertise.
Norlase is a fast-paced entrepreneurial company and will continuously push new innovations to market. You should expect to be involved in the regulatory approval process for new products, incl. FDA 510(k) submissions and CE technical files, as needed.
You enjoy maintaining fundamental quality supporting disciplines like document control, final release etc., but you are also ready when non-conformances occur to step up and facilitate good solutions in close cooperation with your colleagues. You have a natural sense of ownership of the processes that you represent, and you work well in an agile and fast-moving environment.
Your success criterium is that colleagues want you to be in charge when quality issues occur, because you ensure solid solutions in a manner that is constructive and respectful towards your colleagues.
The ideal candidate has at least 3 years of experience within Quality Assurance work in a medical industry company, preferably from medical device production regulated by ISO 13485 or FDA QSR part 820. You hold a bachelor’s degree or higher within Production Engineering or a similarly relevant field.
You communicate fluently in English, both orally and in writing.
Please send your CV and cover letter to Jan Forstberg, via the "Ansøg" link. Send your application now as we will start recruitment process correspondingly.
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