Quality Assurance Officer
Canopus Medical AB / Chefsjobb / Lund
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hela Sverige Visa alla jobb hos Canopus Medical AB i Lund 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 brightening kit for professional use.
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
Perform reviews of Technical Files according to EU MDR
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/ISO 13485
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
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
Computer knowledge in Microsoft Word, Excel, etc
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
Så ansöker du Sista dag att ansöka är 2023-03-08
E-post:
hr@canopusmedical.com Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "Quality Assurance".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Canopus Medical AB (org.nr 559047-7229),
http://www.canopusmedical.com Molekylvägen 1c (
visa karta)
223 63 LUND
Kontakt CEO and Founder
Ali Ismail
ali.ismail@canopusmedical.com +46 708188558 Jobbnummer 7416483
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