QA/RA Manager

Join our mission to help clinicians provide each patient with optimal time to teeth!

As QA/RA Manager you will be working in an international environment, with a professional and highly competent team, supported by world leading partners.

You are committed to quality and regulations and want to ensure that the company guidelines and overall decisions are followed.

You will ensure that Osstell is perceived as a serious, responsible and conscientious company in all external contacts.

Your responsibility include but is not limited to:

• Ensure compliance with applicable laws and regulations.
• Ensure that products are registered in relevant countries
• Manage audits, and being the main point of contact for the Notified Body
• Manage supplier audits
• Ensure the organization´s awareness of the quality management system and applicable regulatory requirements
• Manage the CAPA handling processes
• Perform the role of a Person Responsible for Regulatory Compliance (PRRC)

Qualifications

• Relevant experience from working with quality assurance and regulatory affairs within MedTech
• Demonstrated knowledge of relevant regulations, international standards and guidelines
• Excellent in English, both written and verbally, is a requirement
• Communication in Swedish both verbal and in writing

It is an advantage if you have experience with project management. Furthermore, to have a basic understanding of electronics and/or mechanics.

Why Osstell?

Osstell has a long-term commitment to our customers, employees and partners. We are in it for the long run. Our core values states what we always should focus on; Customer value, Entrepreneurship, Openness and Accountability. We can offer the advantages of being a smaller company with high individual impact, together with the stability of being supported and owned by the W&H Group. Your colleagues are all highly skilled professionals with a profound industry knowledge. Joining Osstell you will be part of a company that has a clear strategy for growth on a global market. We are headquartered in Gothenburg, with a centrally located office.

To apply

This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to ann.rutt@moveup.se

If you have questions regarding Osstell or this open position, please contact Ann at +46 (0)733 44 09 00.

We are screening applications continuously. Please send your CV and Cover letter no later than 14^th of December.

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.