Quality Management Specialist for Occlutech in Helsingborg

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.com