Senior Quality Assurance Specialist
Dfind Science & Engineering AB / Apotekarjobb / Lund
Observera att sista ansökningsdag har passerat.
Visa alla apotekarjobb i Lund,
Lomma,
Staffanstorp,
Burlöv,
Kävlinge eller i
hela Sverige Visa alla jobb hos Dfind Science & Engineering AB i Lund,
Lomma,
Kävlinge,
Malmö,
Eslöv eller i
hela Sverige Senior Quality Assurance Specialist
Are you an experienced QA specialist with an open mind-set who wants to work with positive and dedicated colleagues? Do you want to work in an innovative company with exciting products? If your answer is yes, you may be the candidate we are looking for!
BONESUPPORT, a Swedish medical device company, is now looking for a Quality Assurance Specialist. Here you will conduct audits, both internal across the organization and external as of suppliers/subcontractors, to ensure the Quality Management System operates in a state of compliance and continuous improvement in a global environment. The Quality Assurance Specialist will participate in supplier qualification and assessments. Responsibilities also include participation in continuous improvement activities, ensure adequate documentation and SOP's are in place.to ensure site audit readiness at all times. A part of this position will be to support colleagues in planning of verification and validation studies and review of final reports to verify that methods, procedures and observations are accurately and completely described. Participate in the work to interpret and disseminate information on new or changing regulatory requirements.
You will not only be working closely with colleagues within BONESUPPORT, you will also have contact with subcontractors including suppliers and distributor as well as regulatory authorities. As Quality Assurance Specialist you report to the VP Quality & Regulatory Management.
BONESUPPORT offers a position in an expanding company in an exciting phase where you can make the difference. We look forward to your application!
Qualification:
We are looking for a person with the following experience and qualification:
• Master's degree in science or technology
• 10 years experience with Quality Assurance in a regulated environmentpreferably in the medical device or pharma industry.
• Minimum 5 years' experience from planning, performing and reporting supplier audits and internal audits according to international regulations, as FDA's QSR, ISO 13485 and GXP. Quality auditor certification preferred.
• Implementing and maintaining a quality management system
• Excellent English skills in speech and writing.
On a personal level, you possess excellent communications skills and you strive to deliver results. You prefer to work in a structured way and you have an eye for details. In addition we believe you are a self-motivated person with ability to plan and execute activities with minimal supervision.
We place great emphasis on personal qualities for this role.
Company: BONESUPPORT
City: Lund
Job type: Full time
Deadline for applications: 2017.09.18
More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. The selection process is on-going so please apply as soon as possible, however not later than 2017.09.18. Please send in your application in English via
https://www.dfind.se/science-engineering/To learn more about BONESUPPORT please visit
www.bonesupport.com Organization/Business description:
BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company 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 directly into the bone void.
BONESUPPORT's marketed bio-ceramic bone graft substitutes CERAMENTTM BONE VOID FILLER (BVF), CERAMENTTM G* and CERAMENTTM V* are all based on the Company's novel and proprietary CERAMENT technology platform.
The Company's products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.
BONESUPPORT's total sales increased from SEK 41 million in 2014 to SEK 105 million in 2016, representing a compound annual growth rate of 60 percent. The Company's financial target is to achieve revenue exceeding SEK 500 million in the financial year 2020, with a gross margin exceeding 85 percent and a positive operating profit.
The Company's research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.
BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker "BONEX" (ISIN code: SE0009858152). Further information is available at
www.bonesupport.com• CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States
BONESUPPORTTM and CERAMENTTM are registered trademarks.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-08-25ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-18
Ange följande referens när du ansöker: 201075186
Klicka på denna länk för att göra din ansökanKontaktCamilla WErn 0733-436098
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Styrmansgatan 2
22370 Malmö
KontorsadressStyrmansgatan 2, 21118 Malmö
Jobbnummer 3662216
Observera att sista ansökningsdag har passerat.