Quality Manager

Join our team where we bring out the best in people in our effort to make a difference.

As Quality Manager you are responsible for regulatory and quality compliance related to Document Control in systems and quality processes of Wellspect HealthCare.

Responsibilities
support the Wellspect HealthCare organization with knowledge of document control requirements and to ensure compliance to quality management system requirements.
be responsible for developing, maintaining and managing the document control process
representative in IT projects with specification and validation for implementation of IT systems from a document control perspective in scope of ISO 13485/QSR requirements
you will work with a large number of our employees across function to reduce and LEAN our IT structure within our regulated IT systems and drive our vision moving toward digitalization
support planning and preparation activities related to external and internal audits
setting the future strategy for Wellspect Healthcare solutions for all regulated IT systems within Quality as well as other functions


Qualifications / Background
academic background and longtime experience of working within Quality Assurance with good knowledge of ISO 13485 quality management system that governs medical device products and business.
knowledge and experience of working with specification/implementation of regulatory/quality requirements of IT systems. Knowledge to CFR, part 11, electronic records would be a great plus
hands on experience working with different IT system
a careful, responsible and structured way of working
good communication, writing and interpersonal skills with the ability to manage multiple projects within our QARA group and cross functionally with other departments and work independently
full command of the English and Swedish language, both written and spoken


We think you are an energetic and analytic person who likes to take initiatives and decisions. You are open for challenges and enjoy working together with highly skilled and committed colleagues where every day makes a difference.


We can offer you an exciting and challenging job in a company that is committed to make a difference every day. We have a culture of team spirit where sharing knowledge and finding new ways to tackle challenges together is the key. Part of our vision promote empowerment and “joy is our spice” is important to us. This position is located at our headquarter in Mölndal, Sweden.

For more information, please contact recruiting manager, Annika Loid, telephone +46 761 435713.

Please apply no later than January 24th, 2021. We will review applications continuously, so be sure to send in your application as soon as possible.

Welcome with your application!