Quality & Product Manager (Medical)
Are you a quality and product expert with experience in the medical devices field? Are you a person who loves to keep things in order and create effective processes? We are looking for someone to lead our quality assurance, compliance and product management efforts across our Medical product portfolio. If you think you’re the one, please read on!
Dassiet is a fast-growing company with a focus on sustainable healthcare solutions and materials. Our mold-breaking eco-casts have been on the market since 2010, and we’ve helped treat over 1.5 million patients to date. We are setting the standards for new wave of immobilization and mobility applications – for the benefit of people, animals and the whole planet. Read more about Dassiet at www.dassiet.com
More about our products:
What you will do
- Make sure we are compliant with Finnish, European and international quality standards regarding our medical products
- Manage and update our medical products master data
- Plan and implement quality processes throughout the company
- Communicate quality and product needs with the rest of the teams
- Coordinate with product development, testing and branding to ensure compliance
- Keep key partners and stakeholders such as sales, supply chain and management up to date on product info and quality issues
What we are looking for
- Master's degree in engineering or science
- Experience in regulatory affairs or in quality management systems relating to medical devices (ISO 13485)
- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices (ISO 13485)
- OR four (4) years of professional experience in regulatory affairs or in quality management systems relating to medical devices (ISO 13485).
- M-Files configuration & user skills
- Experience of keep up regulatory compliance of Class I medical devices MDR & FDA. (Including product management tasks related to UDI, GUDID, EUDAMED.)
- Experience of medical device product development according to ISO 13485.
- Excellent teamwork and communications skills
- Good written and spoken Finnish and English
What we offer
- A small and effective team with a vision and passion for making disruptive brands and marketing utilizing modern tools and ways of working
- World’s best products. We have clinically proven, innovative and sustainable products that make human and animal lives better. There’s no need to ‘use the crayons’
- A lean company with clear and transparent growth goals, where everyone has ownership of their work and a chance to affect how we do things.
- Flexibility regarding hours and remote work, and proper work-life balance
- A full-time job with competitive salary & and other benefits
- A nice office with a fridge full of snacks at the Kera Halls (Helsinki city center is so last season) – Right next to micro-breweries, urban farmers, padel courts and modern art! https://www.keranhallit.fi/en/etusivu-english/
Apply & learn more
If the description above sparked something in you, we want to hear from you as soon as possible.
Apply now by sending us your CV and a free form application with subject line ‘Quality & Product Manager’ at firstname.lastname@example.org.
Questions about Dassiet or this position? You can email Kerkko Visuri at email@example.com any time! We’re happy to tell you more about the position and answer your questions.