Quality Management Specialist for Occlutech in Helsingborg
SAM International Executive Sweden AB / Organisationsutvecklarjobb / Helsingborg
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hela Sverige Visa alla jobb hos SAM International Executive Sweden AB i Helsingborg,
Landskrona,
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hela Sverige Are you looking for your new challenge within Quality Management and a company that really makes a great difference in people's lives, then maybe Occlutech is the company to join!
Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at
www.occlutech.com.About the role:
In this role you will support in maintenance, improvement, and development of the existing quality management system. You will report to Global QM Manager and your principle responsibilities will be:
Initiation, Planning, Coordination, supporting, documentation, and monitoring of corrective and preventive actions (CAPA)
Initiation, Coordination, supporting, documentation, and monitoring of changes (Change Control Process)
Control of Documents and records (paper based and within electronical QMS)
Review and approval of product labelling
Cooperation in the risk management team regarding risk identification, - analysing, - evaluation and regular evaluation of residual risk
Close contact, QM support and cooperation with other departments
Preparation of statistics and trend analysis, preparing various reports regarding his responsibilities
Training of employees regarding her/his responsibilities
Support for external Audits (e.g., by Notified Body or authorities)
Planning and performing of internal audits and supplier audits
Who are you?
University degree (at least Bachelor), preferable in the field of engineering, legal or natural sciences
Minimum 3 - 4 years of practical job experience in the fields of Quality Management, Regulatory Affairs, Technical Writing or R&D, preferably in the medical device industry but not a must have.
Knowledge of, and practical experience with, quality management standards and regulatory requirements, such as ISO 13485:2016, MDR, MDSAP, USA 21CFR 820
Strong written and verbal communication skills
Good organizational, interpersonal, and problem-solving skills. Accountable for results and goal attainment.
Ability to work independently with limited supervision, adapt to change and manage multiple tasks.
Ability to collaborate with cross functional teams
Proficiency in Microsoft Office Applications
Are you interested?
We look forward to receiving your application, click on the button below and apply with a cv and personal letter. For further information regarding the position please contact Maria Boström, Executive Search Consultant +46(0)709-141617 or
mbo@sam-int.comPubliceringsdatum2022-07-13Så ansöker duSista dag att ansöka är 2022-08-31
AdressSAM International Executive Sweden AB
Landskronavägen 2
25232 HELSINGBORG
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "QM Specialist Hbg".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare SAM International Executive Sweden AB (org.nr 559245-5470)
Landskronavägen 2 (
visa karta)
252 32 HELSINGBORG
Ansökan E-post:
mbo@sam-int.com Arbetsplats Occlutech International AB
Kontakt Executive Search
Maria Boström
mbo@sam-int.com 0709141617 Jobbnummer 6820916
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