Available position: Quality Assurance Officer
About us
Canopus Medical was founded in 2015 by a group of dermatologists and entrepreneurs, with the passion to develop and manufacture innovative and caring skin care products and medical devices. Our three main areas are:
- Cosmetic skin care development of own face skin brightening kit for professional us
- Development and manufacturing of 3 dermal fillers (medical device Class III)
- Development and manufacturing of a single dose visco-supplementation gel product for knee osteoarthritis (medical device Class III)
Besides developing and commercializing our own products, we also provide contract manufacturing services of many known cosmetic brands in Scandinavia. Our current facilities at the Ideon Science Park in Lund host a pilot scale production plant which is already certified to ISO 22716 (GMP for cosmetic products). We have 9 employees, and we cooperate with several consulting partners. Canopus Medical is planning to scale up the manufacturing capacity during 2023, preparing for the launch of our products and structuring the new organization to match the coming “product in the market” stage. Our current team is multi-cultured, motivated, structured and hard working.
Do you want to make a difference in our creative and challenging journey?
Job description/Main Responsibility
- Perform general QA duties including training of staff, internal inspections, supplier evaluations, certification, audits, etc.
- Continue setting up the QMS for both ISO22716 and ISO13485, as well as start building the future internal compliance and control team
- Assist in compiling European Medical Device Regulation (EU MDR) Technical Files for Notified Body review together with internal and external stakeholder, perform change and gap assessments on Technical Files/Design Dossiers
- Represent the Quality Assurance department in assigned project meetings with internal stake holders and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate
- Prepare product registration documentation for new and amended establishment and product licenses for cosmetics and medical devices
- Perform impact assessments on product design, engineering change and management system planning process outputs
- Check standards and regulations and prepare action plans to mitigate identified compliance and business risks
Required Skills for our new team member
- Master of Science or equivalent degree is the minimum requirement with a major in a scientific discipline
- Regulatory and quality compliance experience in the MedTech industry and experience in manufacturing quality assurance under GMP/ISO13485
- Working knowledge of global medical device regulations
- Ability to work well on cross-functional teams with experience supporting product design and development projects desirable
- Must be able to render clear and accurate judgments
- Computer knowledge in Microsoft Word, Excel, etc
- Excellent written and verbal communication skills
- Team building and networking skills
- Strategic thinking, pragmatic and ability to make decisions
- Ability to work independently in a well-structured and systematic manner
- It is beneficial if you speak Swedish and have experience from start-ups
About the employment:
Working hours: 8-17
We apply a 6-month Probation period
Access will take place as soon as possible
We have a collective bargaining agreement with a trade union
We welcome international applicants
Send your applications to:
hr@canopusmedical.com
For questions regarding the job description:
Ali Ismail, Founder and CEO
Ali.ismail@canopusmedical.com
+46(0)708188558