QARA Consultant
Job Title: Quality Assurance Consultant - Medical Device Remediation (12-Month Contract)
Location: Remote (Germany, Austria, or Poland DACH)
Duration: 12 Months (with potential for extension)
Industry: Medical Devices
About the Role:
We are seeking a highly experienced Quality Assurance Consultant to support a leading Medical Device client on a critical remediation project. This is a fully remote, 12-month contract role, open to candidates based in Germany, Austria, or Poland. You will play a key part in ensuring compliance with EU MDR and other regulatory requirements while supporting ongoing remediation and quality system enhancement activities.
Key Responsibilities:
Support remediation efforts related to design history files (DHFs), technical documentation, and risk management files
Conduct gap assessments and implement corrective actions to align with EU MDR and FDA QSR requirements
Collaborate cross-functionally with Regulatory Affairs, R&D, and Quality Engineering teams
Support audits, CAPA implementation, and document control updates
Develop and update procedures and templates to ensure quality system compliance
Assist in training internal teams on updated processes and compliance standards
Requirements:
Bachelor's degree in Life Sciences, Engineering, or related field
Minimum 5 years' experience in Quality Assurance within the Medical Device industry
Proven experience in remediation projects, especially related to EU MDR
Strong understanding of ISO 13485, EU MDR, FDA 21 CFR Part 820
Excellent communication skills in English (German or Polish is a plus)
Comfortable working independently in a remote, fast-paced environment
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