Senior QA/RA Specialist

Are you intrigued by the opportunity to work as Senior QA/RA Specialist and do you want to contribute to a healthy culture that is characterized byhumility, helpfulness, respect, personal ownership and always with a clear focus on thepatient and people within healthcare?

As Mediplast is growing, they are now expanding their QA/RA team and are looking for a Senior QA/RASpecialist with passion for quality assurance. The position is based in Malmö, Sweden and will reportto the QA/RA Manager.

Main tasks & Responsibility

• Writing and reviewing policies, SOPs and instructions
• Participate as a QA representative at audits and inspections
• Work with investigations, complaints, change control, deviations and CAPA
• Participate in design control projects
• Contribute to risk assessment
• Review and approve process, method and equipment validations
• Act as QA support in the day-to-day operations
• Actively contribute to updates, development and manufacturing
• Authority to fully replace QA/RA manager when absent
• Person Responsible for Regulatory Compliance (PRRC) for Vigilance Reporting according toArticle 15(d) MDR 2017/745

About you

We believe that you have a wide knowledge within QA/RA and experience within R&D andmanufacturing. You are a good administrator with an analytic mindset, always ensuringcompliance. You work in a proactive way and are driving projects together with ProductManagers and other internal stakeholders where collaboration is the key. You are goodcommunicator and have the ability to explain complex situations to the organization at large.For this position fluent Swedish and English, both written and spoken is mandatory.

About the company

Mediplast is part of AddLife group and shares their vision of improving people’s lives by being a leading, value-creating player in Life Science. As a member of this larger Medtech family, we can provide you with additionalconsulting and services, as well as product training.

As a company producing and distributing medical solutions, sustainability is ingrained in our DNA. We recognizethe importance of sustainability and our role in ensuring the long-term viability of our planet and its resources.We are mindful in our use of resources and respectfully implementing sound governance practices andcomplaint behaviour across our organization. We embrace and drive ESG principles in all aspects of ouroperations. At Mediplast we recognize the importance of fostering positive social impact and maintaining strongrelationships with our employees, customers, and communities.

We strongly believe in fostering a culture that is characterized by humility, helpfulness, personal ownership, andrespect amongst each other. By committing to a profound human approach internally, we are convinced thatthis also mirrors our interactions and relationships with our external stakeholders. We believe this is the reasonwhy we are seen as a trusted and engaged partner with a genuine care for people.

For more information about this exciting opportunity, please contact:

Helene Widahl, Rekryteringsspecialisten AB

+46(0)72-961 06 79 or email widahl@rekryteringsspecialisten.se