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Advert-ID: 15087818

Quality Specialist to BONESUPPORT

Quick facts

City:
Lund
Extent:
Full time
Type of work:
Recruitment
Start date:
ASAP
Other:
Full time

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

About the role

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 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, the United States, and several other countries

Job duties

Your key responsibilities will be the following:

  • Support complaint handling and investigation
  • Monitor and analyze quality performance data
  • Perform medical device batch release of finished products
  • Perform quality review and approval of validation and verification plans, change requests etc.
  • Be part of the audit team for internal and supplier audits
  • Support handling of nonconformities and CAPAs
  • Support other activities/projects as relevant

In your role, you will collaborate closely with other parts of the company, e.g. R&D, Operations, Marketing and Sales. Other key relationships are external partners, such as distributors, suppliers, authorities and other external organizations.

We are looking for

  • University degree in Engineering/Life Science or equivalent
  • At least 5 years of work experience from a similar position in the medical device industry
  • Familiar with working in a regulated environment (acquainted with requirements such as European Medical Device Regulation MDD/MDR, MDSAP, US FDA legislation, ISO13485, and relevant ISO standards)
  • Very good knowledge of spoken and written English
  • Good knowledge of MS Office and electronic document management systems

Formal Lead Auditor training/certification would be an advantage but not a requirement as well as experience from working internationally and with combination products.

As a person you are:

  • Quality-oriented
  • Cooperative
  • Adaptable
  • Results-oriented

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, 40h/week
  • 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.

Client information

BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s 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. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021. Please visit www.bonesupport.com for more information.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.

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

Apply here!