Quality Manager
Breas Medical Aktiebolag / Organisationsutvecklarjobb / Härryda
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The Site Quality Manager is responsible for ensuring quality compliance while driving process effectiveness and efficiency at our facility in Mölnlycke, the headquarters of BREAS Medical group. This role will be part of our Global Quality and regulatory team of five people in Sweden, one colleague in the UK and one in the US. Two of the people in Mölnlycke will report to the Site Quality Manager. This position reports to our Global QARA Manager.
BREAS Medical group is in a very interesting phase as the company recently left GE Healthcare and is now a stand-alone-company with new owners. All processes are being worked through to be leaner and more agile, as well as ensuring the high quality needed in a medical device company. At the same time the company is growing very rapidly.
We can offer you a fast changing environment with a very dedicated team. We are all very proud of offering great products and a renowned service level to a global market. Mölnlycke is the home base for everything from R&D to manufacturing and service as well as all the other functions. This offers a great overview of the whole process and being involved in the very core of the business.
Essential responsibilities
• This position will coordinate all quality related work on the site i.e. NC, CAPA complaint investigations and reviews, maintain and develop local QMS compliance to ISO 13485, MDD, Qsreg, Japan, Canada, Taiwan, Brazil.
• Be a quality team representative in different development projects
• Contribute to a good understanding and training of the quality system for all employees.
• Evaluating the efficiency and the effect of the quality systems and report to the management team as required
Qualifications
Your personality:
• As a leader you have the ability to engage and involve your employees and the people around you in the quality work and continuous improvements.
• You enjoy a changing environment and have good ability to prioritize and get things done.
Your experience and competencies:
• Deep knowledge of ISO 13485, QSreg, MDD and ISO 14971
• Experience from driving process development and continuous improvements
• Hands on experience from audits, especially FDA-audits is meritorious
• Earlier managerial experience is seen as an advantage, as well as experience from working in a global and rapid growing company
• Excellent oral and written communication skills in both Swedish and English. More languages are an advantage.
• Relevant University Degree, preferably Bachelor?s Degree in Engineering, Medical Device Technology or Scientific Field
• Minimum of 5 years professional experience
About Breas Medical
Breas Medical is a leading manufacturer of home respiratory ventilators and sleep apnea products for the global home healthcare market sold in more than 40 countries. The company was founded in 1991 in Göteborg and today employs 140 people in nine countries and operates a manufacturing/office facility in Mölnlycke, Sweden. Breas Medical is a portfolio company of PBM Capital Group.
Please visit our website for more information
www.breas.comPubliceringsdatum2014-11-14Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-12-07
Ansökan kan skickas till e-postadress:
career@breas.comKontaktAngela Holecek, Global HR Manager 031-868865 (Kontorstelefon) 0706-106042
angela.holecek@breas.comAnn-Sofie Svensson, Global QARA Manager 031-86 88 31 (Kontorstelefon)
ann-sofie.svensson@breas.comFöretagBREAS MEDICAL AKTIEBOLAG
AdressBREAS MEDICAL AKTIEBOLAG
FÖRETAGSVÄGEN 1
43533 MÖLNLYCKE
KontorsadressFÖRETAGSVÄGEN 1
MÖLNLYCKE
Visa på karta
Övriga kontaktuppgifterTelefonnummer: 031-868800
E-postadress:
career@breas.com Övrig information om företaget/organisationen Offentliga upphandlingar där Breas Medical Aktiebolag varit leverantör Jobbnummer 2067584
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