Quality Specialist to BONESUPPORT

Quality Specialist to BONESUPPORT

"Restoring health to improve the quality of life for patients with bone disorders." The Mission is clear and BONESUPPORT AB want you to be a part of the journey. Here is a chance to contribute with your experience in an agile and creative company with extraordinary products, come and join BONESUPPORT as Quality Specialist!

Information om uppdraget

BONESUPPORT is an innovative and rapidly growing orthobiologics company, based in Lund, Sweden. In 2017, BONESUPPORT AB was listed on the stock exchange. The company has 45 coworkers based in Lund and 55 spread globally. To further strengthen the company, BONESUPPORT is now looking for an experienced and driven Quality Specialist to be a part of our Quality Management & Regulatory Affairs team.

You are offered
  • No boredom! BONESUPPORT is a stimulating workplace where you are challenged daily
  • The opportunity to work for a company whose products are based on interesting technology and a scientifically trustworthy foundation and years of studies
  • An international arena with a global reach and colleagues in Germany, Great Britain, United States and several other countries

Your key responsibilities will be following:
  • Promote the quality mindset and the QMS throughout the organization
  • Suggest and implement quality related process improvements
  • Perform quality review and approval of validation and verification plans, change requests etc.
  • Monitor and analyze quality performance data
  • Be part of the audit team for internal and supplier audits
  • Support handling of nonconformities and CAPAs
  • Train the organization in quality related topics
  • Support other activities/projects as relevant In your role, you will collaborate closely with other parts of the company, e.g. R&D, Manufacturing, Marketing and Sales
  • Support Complaint handling and investigationsupport
Other key relationships are external partners, such as consultants and authorities, distributors and other external organizations.

Vi söker dig som
  • University degree in Life Science or equivalent
  • At least 2 years of work experience from a similar position and from working with medical device technology
  • Familiar in working in a regulated environment (acquainted with requirements such as European Medical Device Regulation MDD/MDR, MDSAP, US FDA legislation and relevant ISO standards)
  • Very good knowledge in spoken and written English
  • Good knowledge of MS Office and electronic document management system.
Formal Lead Auditor training/certification would be an advantage but not a requirement as well as experience from working internationally and with combination products.

At BONESUPPORT we value personal skills as much as professional qualifications, and in this role, personality is crucial for success. You are good at working together with others and can express yourself well both spoken and written. You handle cases independently and you are a performance-driven person who is in a position to keep deadlines and deliver at a high pace. You are analytical and aware of the details and quality. Furthermore, you are focused and structured and have the ability to quickly get involved in new tasks / questions, also when it requires processing of large amounts of information.

At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance. We believe in our journey and take pride in what we do!

Other information
  • Start: Asap/ Upon agreement
  • Work extent: Fulltime
  • Location: HQ in Lund
  • Contact information: This recruitment process is conducted by Academic Work. It is a request from BONESUPPORT that all questions regarding the position are handled by
Academic Work.

Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the screening or interview phase.
Mer info
Område Lund
Yrkesroll Teknik & Ingenjör
Typ av anställning Heltid
Rekrytering hanteras av Academic Work
Hemsida http://www.academicwork.se/
Sista ansökningsdag Löpande (59 dagar kvar)

Om arbetsgivaren

BONESUPPORT . (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patients own bone and have the capability of eluting drugs. BONESUPPORTs bone graft substitutes are based on the patented technology platform CERAMENT. The Company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver and a Premarket approval filing with the FDA (USA) for CERAMENT G is planned in 2021. The company is based in Lund, Sweden, and the net sales amounted to SEK 180 million in 2020. Please visit www.bonesupport.com for more information.

Keywords: QA, quality assurance, quality management, medical devices, MDR, QMS, quality management system