Senior QA/RA Specialist to Mediplast - TILLSATT

We are looking for a Senior QA/RA Specialist to contribute to our healthy culture and expand our QA/RA team. The position is based in Malmö, Sweden and will report to the QA/RA Manager.

Requirements

• 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 to Article 15(d) MDR 2017/745